Questions with Answers_Nitrile Glove Testing.pdf

Question/ Response to RFP 75A50324R00016 Nitrile and Vinyl Glove Testing

Date Questions Submitted: 10/10//2024_____________ Date of Response release: __10/15/2024__

Question

Question Identify Applicable Section of RFP

Identify Applicable RFP Page Number

RESPONSE

1 Testing for ISO 10993 is not usually done as frequently as the other tests called out so we are treating sampling on these tests differently. Is this the approach you anticipate working with?

N/A N/A Test sampling for ISO 10993 (biocompatibility) may be different or separate than test sampling for ASTM D6319 and ASTM D5250.

Can you confirm that USP Sterility testing is not required?

N/A N/A Sterility testing is not required; the nitrile and vinyl gloves are non-sterile.

3 We would like to clarify the specific services that are required to be performed on-site at your facility and those that can be completed at our contractor's facility.

As outlined in the RFP, the project involves equipment calibration and glove validation.

Please confirm if there are any aspects of these services that must be carried out on-site.

Additionally, we would like to understand if there are any specific requirements or restrictions regarding the on-site work, such

N/A N/A All glove testing, per the solicitation, must be performed at an ISO 17025 accredited laboratory; glove testing will not be performed at the USG facility. The Contractor will not be required to perform any services onsite except for validating the glove samples (by lot number) pulled by the facility’s warehouse staff.

as access to equipment, facilities, or personnel.

Your clarification will help us better plan our resources and ensure that we can meet all the project requirements efficiently.

4 Can you provide the pick-up location for the gloves? The SOW has the location as TBD.

N/A N/A The address(es) will be provided by the COR after award and will be to a Government designated location within the continental United States

(CONUS).

5 What is the lot size and AQL per manufacturer? The lot size is needed to be able to determine the correct sample size for testing.

N/A N/A The lot sizes are provided in Table A and Table B in the solicitation. For lot numbers with multiple manufacturers, sampling needs shall be based on each manufacturer producing >35,000 gloves.

Per 21 CFR 800.20, the AQL for sample testing patient examination gloves is 2.5; 2.5 AQL shall be used for testing the nitrile and vinyl nitrile blend examination gloves for this solicitation.

6 I was told that we do not need to sample gloves and will be sent to us, correct?

N/A N/A The Government anticipates shipping the product to the Contractor unless the Contractor's protocol for chain of custody is for the Contractor to pick up glove samples from the Government facility. The

Contractor shall inform the Government on their process and protocol for receiving glove samples for testing and maintaining chain of custody.

Refer to Task 4.6 in the Solicitation.