Replacement Attachment C - Gloves.docx

70FA2020R00000011 Attachment C – Gloves Background

The mission of the Division of Strategic National Stockpile (DSNS), of the United States (U.S.) Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters or other emerging infectious disease agents. When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, DSNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event.

The Strategic National Stockpile (SNS) is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. These assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that causes local supplies to run out.

Protection of healthcare workers and first responders from transmission of pathogens is essential to maintaining resilience of the U.S. healthcare system. Non-Sterile, Powder-Free, Patient Examination Gloves are one part of an infection control strategy and are examples of personal protective equipment (PPE) that is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. The appropriate use of PPE is an important component of the overall strategy of certain infection control guidelines.

Purpose

The U.S. Government is interested in establishing multiple awards for immediate purchases of Non-Sterile, Powder-Free, Patient Examination Gloves used in healthcare settings as described below. This will enable the United States to ensure sufficient availability of such items during national emergencies and/or pandemic events. The Government is concerned about the risks of disruption of any manufacturing facilities or supply chains located outside of the United States. Thus, offerors are advised to pay special attention to the instructions regarding manufacturing capability and/or supply chains located outside of the United States as well as the evaluation criteria related to manufacturing capability and foreign supply chains. The Government is concerned about the risks related to excessive pricing of critical PPE and intends only to acquire PPE at prices that it can determine are fair and reasonable. Thus, offerors are advised to pay special attention to the instructions regarding pricing.

The following is a list to provide clarification about the different types of acceptable Non-Sterile, Powder-Free, Patient Examination Gloves to protect against contamination that may be proposed as part of the requirement:

Patient Examination gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations. Patient examination gloves are reviewed and cleared by the Federal and Drug Administration (FDA) as Class I reserved medical devices that requires a 510(k) premarket notification requiring registration and listing, under 21 CFR 880.6250.

Under the current FDA enforcement discretion (guidance), prior submission of a premarket notification under section 510(k), Registration and Listing requirements, Quality System Regulation requirements, reports of corrections and removals, and Unique Device Identification requirements are not required under COVID-19 emergency response declarations. FDA currently believes such devices would not create such an undue risk where the product is labeled as follows:

· The product includes labeling that accurately describes the product as an “unpowdered glove” (as opposed to a surgeon’s or patient examination glove), accurately describes its sterility status when individually packaged (non-sterile), does not claim the product as being free of a specific material (e.g., latex free), and includes a list of the body contacting materials;

· The product includes labeling with general statements and makes recommendations that would reduce sufficiently the risk of use, for example, a general statement about devices that have not been cleared by FDA and recommendations against use: when FDA-cleared gloves are available, in surgical settings or where significant exposure to liquid bodily or other hazardous fluids may be expected, and in clinical settings where the infection risk level is high; and

· The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses with chemotherapy drugs, fentanyl, and other opioids, uses for allergy or dermatitis prevention, uses for antimicrobial or antiviral protection, or uses for infection prevention or reduction.

a) Nitrile, Latex, Vinyl (PVC), or Polymer other than Vinyl patient examination gloves

b) Length requirements for patient examination gloves must be a minimum of 220mm-230mm (8.6”- 9”) depending on glove size and material type

c) Glove thickness for patient examination gloves must be a minimum of 5- 8 mm depending on the glove material type and location (palm or finger)

d) Tensile strength and ultimate elongation before and after the accelerated aging as identified in relevant American Society for Testing and Materials (ASTM) standards

e) Residual powder testing per ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves. Water leakage testing per FDA 1000 mL test method (21 CFR 800.20) or ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves to assess barrier integrity.

Scope of Work

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all labor, materials, supplies, facilities, equipment, transportation and travel necessary to deliver one or more of the following acceptable Non-Sterile, Powder-Free, Patient Examination Gloves. Preference will be given in order by:

· Nitrile, Non-Sterile, Powder-Free, Patient Examination Gloves

· Must meet ASTM D6319-19 standard specifications

· Must be registered and listed with FDA

· Must be snug or form fitting patient examination gloves

· Equivalent or similar to Dynarex #2513

· Extra Small, Small, Medium, Large, Extra Large

· Latex, Non-Sterile, Powder-Free, Patient Examination Gloves

· Must meet ASTM D3578-19 standard specifications

· Must be registered and listed with FDA

· Must be snug or form fitting patient examination gloves

· Equivalent or similar to Medline #CUR8106

· Extra Small, Small, Medium, Large, Extra Large

· Non-Latex, Non-Sterile, Powder-Free, Patient Examination Gloves (PVC/Polychloroprene)

· Must meet ASTM D5250-19 standard specifications (for Poly (vinyl chloride) or ASTM D6977 standard specifications (for polychloroprene)

· Must be registered and listed with FDA

· Must be snug or form fitting patient examination gloves

· Equivalent or similar to Innovative Healthcare #161300 or Smart Practice #433467

· Extra Small, Small, Medium, Large, Extra Large A combination of the gloves described above may be acceptable to meet the Government’s requirement.

Declaration of conformity to applicable standards listed above must be provided.

Offerors shall disclose and identify the following the following information

1. FDA Registration and date registered (if applicable)

2. FDA Listings and date listed for respective gown FDA product codes (if applicable)

3. FDA Premarket Document Number (e.g. 510k clearance) for respective product codes proposed (if applicable)

Product manufacturer and part number, description, and literature must be included in the proposal for consideration and mapped to appropriate FDA Product Codes.