SPE1C120R0137 Amendment 0001 Beta.Sam.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO.

See Block 14

4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

6. ISSUED BY CODE SPE1C1 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

CODE FACILITY CODE

SPE1C120R0137

X

2020 JUL 20

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of OffersX is extended, X is not extended.

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

12. ACCOUNTING AND APPROPRIATION DATA (If required)

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO.

IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc. ) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

E. IMPORTANT: Contractor is not, X is required to sign this document and return 1 copies to issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A NAME AND TITLE OF SIGNER (Type or print)

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

16B. UNITED STATES OF AMERICA15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

(a) By completing Items 8 and 15, and returning

DLA TROOP SUPPORT

C AND T SUPPLY CHAIN

700 ROBBINS AVENUE

PHILADELPHIA PA 19111-5096

15C. DATE SIGNED 16C. DATE SIGNED

D. OTHER (Specify type of modification and authority)

07/22/2020

3. EFFECTIVE DATE

See Attached Continuation Sheet(s).

(X)

CHECK ONE

9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

13. THIS APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED:

CONTINUED ON NEXT PAGE

PAGE 2 OF 3 PAGES

SPE1C120R0137 - 0001

The following changes are made to the solicitation and/or its attachments:

1. The proposal submission form attached to the solicitation is hereby deleted and replaced with the revised proposal submission form attached to this amendment. It is solely the offeror’s responsibility to ensure this revised proposal submission form is used when submitting its proposal.

2. The following provisions/clauses are hereby deleted from the solicitation:

252.204-7004 LEVEL I ANTITERRORISM AWARENESS TRAINING FOR CONTRACTORS

252.204-7009 LIMITATIONS ON THE USE OR DISCLOSURE OF THIRD-PARTY CONTRACTOR REPORTED CYBER INCIDENT INFORMATION 252.204-7012 SAFEGUARDING COVERED DEFENSE INFORMATION AND CYBER INCIDENT REPORTING

52.211-5 MATERIAL REQUIREMENTS

252.204-7008 COMPLIANCE WITH SAFEGUARDING COVERED DEFENSE INFORMATION CONTROLS

3. Please use the solicitation’s mailbox DLATSSurgicalDisposableGowns20R0137@dla.mil, to correspond with the contracting team (Monique Porter, Robert Fagan and Daniel Engelberg), in lieu of the phone numbers listed at the top of page 3 of the solicitation. Use of the mailbox greatly facilitates the handling of questions in a timely manner.

4. Answers to frequently asked questions received in response to this solicitation will be periodically posted to the Beta.SAM.Gov website as an attachment to the initial posting issued on July 20, 2020. Offerors should periodically check to see if answers are posted to their questions prior to submitting their questions to DLATSSurgicalDisposableGowns20R0137@dla.mil.

5. The contractor is required to sign this amendment and return one copy to the issuing office.

6. All other terms and conditions remain the same.

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 3 OF 3 PAGES

SPE1C120R0137 - 0001

Attachments

List of Attachments

File Name Description ATTACH_Revised_Dispos able_Surgical_Gown_Sub mission_Form

Revised Disposable Surgical Gown Submission

Form-.pdf

Source Selection Information See FAR 2.101 & 3.104

REVISED PROPOSAL SUBMISSION FORM FOR DISPOSABLE SURGICAL

GOWN UNDER SOLICITATION SPE1C1-20-R-0137

COMPANY: _______________________________________ GOWN LEVEL: __________________

LOT SUBMITTED UNDER: _______________________________________

SOURCE OF SUPPLY: _______________________________________

The following document is provided to assist you in preparing your proposal for solicitation SPE1C1-20- R-0137. Please review the addendum to 52.212-1 Instructions to Offeror – Commercial Items for instructions on how many forms are required if you plan on submitting multiple places of performance, fabric suppliers, and/or sources of supply. If you are submitting your proposal under any of the Berry Compliant sub-lots (1A, 2A, and 3A), you shall complete #1. If you are submitting your proposal under any of the Buy American Act Compliant End Items from Domestic or Qualifying Countries or Provide an End Item Whose Primary End Item Fabric is Manufactured in the United States sub-lots (1B, 2B, and 3B), you shall complete #2. If you are submitting your proposal under any of the Trade Agreement Act Compliant sub-lots (1C, 2C, and 3C), you do not need to complete #1 or #2.

1. Offerors are cautioned that there is a strong preference for an item in which all components are of domestic origin in compliance with clause 252.225-7012, Preference for Certain Domestic Commodities (DEC 2012), often referred to as the Berry Amendment. Please note that the gown being acquired under this lot of this solicitation is considered to be an item of clothing for purposes of the Berry Amendment.

I, (name) do hereby confirm by signature below that all articles or items of “clothing,” including the materials and components thereof, being offered for sale to the Department of Defense have been grown, reprocessed, reused, or produced in the United States, other than sensor, electronics, or other items added to, and not normally associated with, clothing (and the materials and components thereof).

Signature: ____________________________________________________

2. By completing this section, you are certifying that your product does not comply with the Berry Amendment and certify that the item being provided that is:

[ ] Buy American Act Compliant End Item from a Domestic and/or Qualifying Country

Country of End Item Manufacture: _____________________________________ [ ] An item whose primary end item fabric is manufactured in the United States

I, (name) do hereby certify by signature below that the item being proposed under this lot meets the requirements indicated by the option checked above.

Signature:

Please provide the following information in the boxes provided. Once complete, you are to attach the documents listed herein to this form via the paperclip icon in Adobe. If the information required herein is not completed directly in this form, your proposal will be considered nonresponsive and will be rejected as it does not meet the terms and conditions of the solicitation making the proposal ineligible for award.

1. Minimum Quantity Acceptable for Award: The offeror will not accept a contract for less than

_______________________________________________ each.

2. Delivery Capabilities: The offeror shall enter the quantity of gowns it can provide within the time periods listed below. Please note that this is not a running total and the quantities you enter below are what you will be required to deliver on that date if you should receive a contract based on your proposal. As listed in the solicitation, offerors may submit offers under multiple lots;

however, individual proposal submission forms and PDMs shall be submitted per place of performance. If an offeror is planning to use multiple fabric suppliers, it shall include the test data/CoCs outlined in the proposal submission form for each fabric supplier; however, only one

(1) PDM is required.

Furthermore, offerors are cautioned that this solicitation, and the other two (2) solicitations issued by this office for gowns are independent of each other. Therefore, any awards resulting from these solicitations are independent of each other. If an offeror plans on submitting a proposal under multiple solicitations, they shall factor in their capacity and allocate it accordingly. If an offeror receives multiple awards under any of these solicitations, including awards for multiple lots and/or gown types, delivery dates will not be revised/extended from the proposed schedule the offeror provides below. All three (3) solicitations require delivery within 30 days of award and multiple awards may include overlapping deliveries.

September 30, 2020 October 31, 2020 November 30, 2020 December 31, 2020 January 31, 2021

February 28, 2021 March 31, 2021 April 30, 2021 May 31, 2021 June 30, 2021

July 31, 2021 August 31, 2021 September 29, 2021

3. Monthly Maximum Capacity: ______________________ per month. Note, if an award is made based on this proposal, the Government will not place delivery orders that exceed this quantity within any 30 day period.

4. Unit Price: $ each NOTE: Offerors shall provide one (1) unit price that is applicable to all sizes. This price will be used for price evaluation purposes; however, all contract awards will be issued with a unit of issue being a full pallet quantity (which you shall list on page seven (7) of this form). The award price will therefore be the unit price listed here multiplied by the quantity per pallet you list on page seven (7) of this form.

5. Sizes. Offerors shall submit proposals that contain all of the sizes listed below. The below size tariff represents the percentage of each size the Government estimates it will order of the awarded quantity; however, the Government reserves the right to order any combination of sizes. Offerors shall check the below box to certify that the proposal and unit price include the below listed sized.

[ ] This proposal includes all five (5) sizes.

Small Medium Large Extra-Large 2X-Large

5% 5% 40% 40% 10%

6. Authorized Negotiators: The offeror represents that the following person is authorized to negotiate on its behalf with the Government in connection with this request for proposal. Please list names, titles, e-mail addresses, and telephone numbers for each authorized negotiator. As noted in the solicitation, awarding contract(s) based on initial proposals is planned.

Name: ________________________________________________

Title: ________________________________________________

Email Address: ________________________________________________

Telephone Number: ________________________________________________

7. If you are a large business (NAICS code 339113 / 750 employees) a small business subcontracting plan is required in accordance with FAR 52.219-9 Small Business Subcontracting Plan (MAR 2020). You shall title the PDF of this document as “Small Business Subcontracting Plan” and attach it to this form.

8. FAR 52.215-6 -- Place of Performance applies.

(a) The offeror or respondent, in the performance of any contract resulting from this solicitation, [ ] intends, [ ] does not intend [“X” the applicable block] to use one or more plants or facilities located at a different address from the address of the offeror or respondent as indicated in this proposal or response to request for information.

(b) If the offeror or respondent checks “intends” in paragraph (a) of this provision, it shall insert in the following spaces the required information:

Place of Performance(Street Address, City, State, County, Zip Code):

Name and Address of Owner and Operator of the Plant or Facility if Other Than Offeror or Respondent:

9. Procurement Note Identification of Sources of Supply. Contractors shall list the sources of supply for all materials/components used in the manufacture of this item. This includes base fabric/material, thread, rubber/elastics, etc. that will be used in the manufacture of this gown. This information will be redacted from any resultant award made from your offer.

(a) Offeror shall complete the following for the materials used in the manufacture of its proposed items

Material #1: ________________________________________________ Manufacturer (including address) of the material:

Material #2: ________________________________________________

Material #3: ________________________________________________

Material #4: ________________________________________________

Material #5: ________________________________________________

1. As part the product demonstration model evaluation factor, you shall complete the below page(s) in this document. You shall label the attachments exactly as listed below in bold font and attach them to this form via the Adobe attachment function (paperclip icon). The attachments are as follows:

• Photographs & Technical Drawings. Photograph(s) and/or technical drawing(s) for EACH size and fabric or basic material for the Disposable Surgical Gown manufactured at the facility listed in your response to FAR 52.215-6 Place of Performance under the proposal submission form. Color and basic material shall be identified.

• Test Reports and CoCs. Copies of all test reports and CoCs referenced below. Test reports shall be from an ISO 17025 accredited testing facility. TEST REPORTS ARE REQUIRED for the following and shall be submitted as ONE document and titled as required herein:

o Barrier Performance – AATCC 127 and AATCC 42 Lab Reports for Barrier Performance for the corresponding protection level of gown (Level 4 Only - ASTM F1671 Lab Report) o Tensile Strength – ASTM D5034 Lab Reports for the corresponding protection level of the gown o Tear resistance – ASTM D5587 (woven textiles) or ASTM D5733 (nonwoven textiles) Lab Reports for the corresponding protection level of gown o Seam Strength – ASTM D751 lab reports for the corresponding protection level of gown o Lint Generation –document lint generation as specified in ISO 9073 Part 10 o Evaporative Resistance – ASTM F1868, Part B lab reports for the corresponding protection level of gown o Water Vapor Transmission Rate – ASTM D6701 lab reports for the corresponding protection level of gown o Sterility Assurance Level – provide proof of sterility assurance level of at least 10-6

(ISO 11134, ISO 11135, ISO 11137, ISO 13683)

o Biocompatibility – Certification or lab reports under ISO/ANSI/AAMI 10993-10 for corresponding protection level of gown o Flammability – lab report for class 1 flammability in accordance with 16 CFR Part

1610)

• FDA Certification. U.S. Food and Drug Administration (FDA) information for each disposable surgical gown offered and shall be submitted as ONE document and titled as required herein:

o Registration and date registered.

o Listings and date listed for FDA product code of "FYA".

o Premarket document number (510(k) clearance) for FDA product code of "FYA".

Offerors shall follow the directions in the solicitation for submission of PDMs. The timeliness of PDM submission will be based on the tracking information provided by the offeror. The offeror shall provide the carrier name (must ONLY be either UPS/Federal Express) and tracking number below:

Carrier Name: ______________________________________

REVISED PROPOSAL SUBMISSION FORM – TEST DATA SUB-FACTOR OF PDM EVALUATION FACTOR

Tracking Number: ___________________________________

2. Product dimensions, in inches, for EACH size of Disposable Surgical Gown manufactured at the facility listed in your response to FAR 52.215-6 Place of Performance (all dimensions measured with the Gown laying flat, with the back closed.) Product dimensions shall include the following at minimum:

a. Chest Finished Width, measured from folded edge to folded edge, one inch below the armholes.

b. Finished Length, measured from the highest point of neck opening straight down to the bottom edge of the Gown.

c. Sleeve Length, measured from the shoulder seam to the bottom edge of the cuff. If the Gown utilizes raglan sleeves or other designs lacking a traditional shoulder seam, the Sleeve Length may be measured from neck opening or other suitable reference point as long as the reference point is identified along with the measured length.

[ ] Please affirm that the proposed gown does not contain latex by checking this box as gowns containing latex are not acceptable.

Manufacturing Information (Place applicable information in this column) Manufacturer Manufacturer's CAGE Manufacturer's Part Number Product's Country of Origin

Product Data / Information (Place applicable information in this column) Number of Gowns per Case/Pack (QUP) Number of Cases per Pallet Number of Gowns per Pallet Gown Material Color(s) Offered Chest Measurement (in inches) – SMALL Back Length (in inches) – SMALL Sleeve Length (in inches) - SMALL Chest Measurement (in inches) – MEDIUM Back Length (in inches) – MEDIUM Sleeve Length (in inches) – MEDIUM Chest Measurement (in inches) – LARGE Back Length (in inches) – LARGE Sleeve Length (in inches) – LARGE Chest Measurement (in inches) – XL Back Length (in inches) – XL Sleeve Length (in inches) – XL Chest Measurement (in inches) – 2XL

Back Length (in inches) – 2XL Sleeve Length (in inches) – 2XL

Requirements - The table below provides a list for all requirements and supporting lab reports necessary for a successful technical evaluation. Offerors shall provide the documentation listed below in one (1) PDF document entitled “Test Reports and CoCs” and indicate the page number the below information can be located on.

# Requirement Page Number Information is Located On

Barrier Performance – AATCC 127 and AATCC 42 Lab Reports for Barrier Performance for the corresponding protection level of gown (Level 4 Only - ASTM F1671 Lab Report)

Tensile Strength – ASTM D5034 Lab Reports for the corresponding protection level of the gown

Tear resistance – ASTM D5587 (woven textiles) or ASTM D5733 (nonwoven textiles) Lab Reports for the corresponding protection level of gown

Seam Strength – ASTM D751 lab reports for the

Lint Generation –document lint generation as specified in ISO 9073 Part 10

Evaporative Resistance – ASTM F1868, Part B lab reports for the corresponding protection level of gown

Water Vapor Transmission Rate – ASTM D6701 lab reports for the corresponding protection level of gown

Sterility Assurance Level – provide proof of sterility assurance level of at least 10-6 (ISO

11134, ISO 11135, ISO 11137, ISO 13683)

Biocompatibility – Certification or lab reports under ISO/ANSI/AAMI 10993-10 for

Flammability – lab report for class 1 flammability in accordance with 16 CFR Part 1610)

11 U.S. FDA Registration and Date Registered

Listing and Date Listed for FDA Product Code of

“FYA”

Premarket Document Number (510(k) Clearance) for FDA product code of “FYA”

NOTE: Under no circumstances will the Government accept blanket statements of an items ability to meet the Government needs. Offerors shall provide the above which fully demonstrate the proposed items ability to meet the Government’s need. Any proposal received that provides a blanket statement without supporting documentation shall be considered non-responsive and will be rejected.

Past Performance Record #1 Description of the Item(s) Provided:

Contract Number/Other Identification:

Contract Holder Name and Address:

Points of Contact Contract Holder:

Contract Award Date and Ending Date:

Total Contract Length:

Contract Type:

Number of Customers:

Number of Delivery Points:

Maximum Contract Dollar Value:

Annual Dollar Value (if an LTC):

Maximum Monthly Production Quantity:

Quality Issues if Experienced:

For substandard quality, the offeror shall specifically address any warranty actions taken, quality deficiency reports issued, or returned merchandise (including one-for-one exchanges).

The description of the problem shall also include an explanation for its occurrence, a clear plan or evidence of measures taken to preclude a recurrence, and whether or not it was the offeror’s fault or subject to mitigating circumstances.

REVISED PROPOSAL SUBMISSION FORM – PAST PERFORMANCE DATA

As listed in the solicitation, you shall provide past performance information on three (3) of your most recent awards for the same and/or similar items. Enter the information in the below table ONLY. If there is no available past performance for the same/ or similar items, provide your most recent performance on any government or commercial contract(s) that best demonstrate your capabilities. If you are using a different facility to manufacture these items as listed in your response to FAR 52.215-6 Place of Performance, provide two (2) records of your own past performance experiences and one (1) record for the company listed in your response to this clause.

Total Number of Deliveries That Were Made Ahead of Schedule/Were Early Total Number of Deliveries That Were Made on Time Total Number of Deliveries That Were Late Mitigating Circumstances Regarding Late Deliveries:

Steps Taken to Correct Delivery Problems if Experienced:

Problems or Discrepancies if Experienced:

Please include a description of how these problems were handled, the timeliness of your response/action, the corrective action taken, and if there was any urgency to the problem(s).

Past Performance Record #2 quality deficiency reports issued, or returned merchandise (including one-for-one exchanges).

The description of the problem shall also include an explanation for its occurrence, a clear plan or evidence of measures taken to preclude a recurrence, and whether or not it was the offeror’s fault or subject to mitigating circumstances.

Total Number of Deliveries That Were Made Ahead of Schedule/Were Early Total Number of Deliveries That Were Made on Time Total Number of Deliveries That Were Late Mitigating Circumstances Regarding Late Deliveries:

Steps Taken to Correct Delivery Problems if

Past Performance Record #3 quality deficiency reports issued, or returned merchandise (including one-for-one exchanges).

The description of the problem shall also include an explanation for its occurrence, a clear plan or evidence of measures taken to preclude a recurrence, and whether or not it was the offeror’s fault or subject to mitigating circumstances.

Total Number of Deliveries That Were Made Ahead of Schedule/Were Early Total Number of Deliveries That Were Made on Time Total Number of Deliveries That Were Late Mitigating Circumstances Regarding Late Deliveries:

Steps Taken to Correct Delivery Problems if

COMPANY:

SOURCE OF SUPPLY:

I name:

Country of End Item Manufacture:

do hereby:

each:

September 30 2020Row1:

October 31 2020Row1:

November 30 2020Row1:

December 31 2020Row1:

January 31 2021Row1:

February 28 2021Row1:

March 31 2021Row1:

April 30 2021Row1:

May 31 2021Row1:

June 30 2021Row1:

July 31 2021Row1:

August 31 2021Row1:

September 29 2021Row1:

Monthly Maximum Capacity:

Unit Price:

noted in the solicitation awarding contracts based on initial proposals is planned:

undefined:

Email Address:

Telephone Number:

Place of PerformanceStreet Address City State County Zip Code:

Respondent:

Material 1:

Manufacturer including address of the material:

Material 2:

Manufacturer including address of the material_2:

Material 3:

Manufacturer including address of the material_3:

Material 4:

Manufacturer including address of the material_4:

Material 5:

Manufacturer including address of the material_5:

Carrier Name:

Tracking Number:

Place applicable information in this columnManufacturer:

Place applicable information in this columnManufacturer s CAGE:

Place applicable information in this columnManufacturer s Part Number:

Place applicable information in this columnProduct s Country of Origin:

Place applicable information in this columnNumber of Gowns per CasePack QUP:

Place applicable information in this columnNumber of Cases per Pallet:

Place applicable information in this columnNumber of Gowns per Pallet:

Place applicable information in this columnGown Material:

Place applicable information in this columnColors Offered:

Place applicable information in this columnChest Measurement in inches SMALL:

Place applicable information in this columnBack Length in inches SMALL:

Place applicable information in this columnSleeve Length in inches SMALL:

Place applicable information in this columnChest Measurement in inches MEDIUM:

Place applicable information in this columnBack Length in inches MEDIUM:

Place applicable information in this columnSleeve Length in inches MEDIUM:

Place applicable information in this columnChest Measurement in inches LARGE:

Place applicable information in this columnBack Length in inches LARGE:

Place applicable information in this columnSleeve Length in inches LARGE:

Place applicable information in this columnChest Measurement in inches XL:

Place applicable information in this columnBack Length in inches XL:

Place applicable information in this columnSleeve Length in inches XL:

Place applicable information in this columnChest Measurement in inches 2XL:

Back Length in inches 2XL:

Sleeve Length in inches 2XL:

Page Number Information is Located OnBarrier Performance AATCC 127 and AATCC 42 Lab Reports for Barrier Performance for the corresponding protection level of gown Level 4 Only ASTM F1671 Lab Report:

Page Number Information is Located OnTensile Strength ASTM D5034 Lab Reports for the corresponding protection level of the gown:

Page Number Information is Located OnTear resistance ASTM D5587 woven textiles or ASTM D5733 nonwoven textiles Lab Reports for the corresponding protection level of gown:

Page Number Information is Located OnSeam Strength ASTM D751 lab reports for the corresponding protection level of gown:

Page Number Information is Located OnLint Generation document lint generation as specified in ISO 9073 Part 10:

Page Number Information is Located OnEvaporative Resistance ASTM F1868 Part B lab reports for the corresponding protection level of gown:

Page Number Information is Located OnWater Vapor Transmission Rate ASTM D6701 lab reports for the corresponding protection level of gown:

Page Number Information is Located OnSterility Assurance Level provide proof of sterility assurance level of at least 106 ISO 11134 ISO 11135 ISO 11137 ISO 13683:

Page Number Information is Located OnBiocompatibility Certification or lab reports under ISOANSIAAMI 1099310 for corresponding protection level of gown:

Page Number Information is Located OnFlammability lab report for class 1 flammability in accordance with 16 CFR Part 1610:

Page Number Information is Located OnUS FDA Registration and Date Registered:

Page Number Information is Located OnListing and Date Listed for FDA Product Code of FYA:

Page Number Information is Located OnPremarket Document Number 510k Clearance for FDA product code of FYA:

Description of the Items Provided:

Contract NumberOther Identification:

Contract Holder Name and Address:

Points of Contact Contract Holder:

Contract Award Date and Ending Date:

Total Contract Length:

Contract Type:

Number of Customers:

Number of Delivery Points:

Maximum Contract Dollar Value:

Annual Dollar Value if an LTC:

Maximum Monthly Production Quantity:

Quality Issues if Experienced For substandard quality the offeror shall specifically address any warranty actions taken quality deficiency reports issued or returned merchandise including oneforone exchanges The description of the problem shall also include an explanation for its occurrence a clear plan or evidence of measures taken to preclude a recurrence and whether or not it was the offerors fault or subject to mitigating circumstances:

Total Number of Deliveries That Were Made Ahead of ScheduleWere Early:

Total Number of Deliveries That Were Made on Time:

Total Number of Deliveries That Were Late:

Mitigating Circumstances Regarding Late Deliveries:

Steps Taken to Correct Delivery Problems if Experienced:

Problems or Discrepancies if Experienced Please include a description of how these problems were handled the timeliness of your responseaction the corrective action taken and if there was any urgency to the problems:

Description of the Items Provided_2:

Contract NumberOther Identification_2:

Contract Holder Name and Address_2:

Points of Contact Contract Holder_2:

Contract Award Date and Ending Date_2:

Total Contract Length_2:

Contract Type_2:

Number of Customers_2:

Number of Delivery Points_2:

Maximum Contract Dollar Value_2:

Annual Dollar Value if an LTC_2:

Maximum Monthly Production Quantity_2:

Quality Issues if Experienced For substandard quality the offeror shall specifically address any warranty actions taken quality deficiency reports issued or returned merchandise including oneforone exchanges The description of the problem shall also include an explanation for its occurrence a clear plan or:

evidence of measures taken to preclude a recurrence and whether or not it was the offerors fault or subject to mitigating circumstances:

Total Number of Deliveries That Were Made Ahead of ScheduleWere Early_2:

Total Number of Deliveries That Were Made on Time_2:

Total Number of Deliveries That Were Late_2:

Mitigating Circumstances Regarding Late Deliveries_2:

Steps Taken to Correct Delivery Problems if Experienced_2:

Problems or Discrepancies if Experienced Please include a description of how these problems were handled the timeliness of your responseaction the corrective action taken and if there was any urgency to the problems_2:

Description of the Items Provided_3:

Contract NumberOther Identification_3:

Contract Holder Name and Address_3:

Points of Contact Contract Holder_3:

Contract Award Date and Ending Date_3:

Total Contract Length_3:

Contract Type_3:

Number of Customers_3:

Number of Delivery Points_3:

Maximum Contract Dollar Value_3:

Annual Dollar Value if an LTC_3:

Maximum Monthly Production Quantity_3:

Quality Issues if Experienced For substandard quality the offeror shall specifically address any warranty actions taken:

quality deficiency reports issued or returned merchandise including oneforone exchanges The description of the problem shall also include an explanation for its occurrence a clear plan or evidence of measures taken to preclude a recurrence and whether or not it was the offerors fault or subject to mitigating circumstances:

Total Number of Deliveries That Were Made Ahead of ScheduleWere Early_3:

Total Number of Deliveries That Were Made on Time_3:

Total Number of Deliveries That Were Late_3:

Mitigating Circumstances Regarding Late Deliveries_3:

Steps Taken to Correct Delivery Problems if Experienced_3:

Problems or Discrepancies if Experienced Please include a description of how these problems were handled the timeliness of your responseaction the corrective action taken and if there was any urgency to the problems_3:

Dropdown1: [Select Level]

Dropdown2: [Select Lot]

BAA Option: Off

Check Box5: Off

Place of Performance: Off

Check Box6: Off

Clear Form: