Nitrile Exam Glove RFI Attachment 1.docx

Nitrile Exam Glove Request for Information (RFI) Attachment 1

Company name:

Business size:

Address:

Point of contact information:

Minimum Requirements:

1. Be a domestic end-product in alignment with Section 1 of Executive Order (E.O.) 14005, Ensuring the Future is Made in All of America by All of America's Workers.

Vendor Narrative Response:

2. Meet or exceed relevant American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO) standards shown below:

· ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers

· ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves

· ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application

· ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves

· ASTM D6978: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

· ASTM F1671: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

· ISO 10993: Biological Evaluation of Medical Devices Vendor Narrative Response:

3. Provide balanced durability tensile strength (ASTM D412), and tactile sensitivity (ASTM D3767) sufficient for sustained use in high‑volume medical environments without tearing, excessive fatigue, or compromised performance.

Vendor Narrative Response:

5. Demonstrate resistance to chemotherapy and other hazardous drugs. Testing shall have been performed against a broad panel of drugs, totaling not fewer than 50 drugs, to ensure suitability for oncology and hazardous drug handling (ASTM 6978). The drugs tested must come from the ASTM 6978 standard and/or the National Institute for Occupational Safety and Health (NIOSH) List of Hazardous Drugs in Health Care Settings found here,https://www.cdc.gov/niosh/publications/hcp/numbered/2025-103.html Vendor Narrative Response:

6. Provide proven barrier protection against fentanyl and gastric acid permeability, ensuring safety in emergency, laboratory, and field clinical scenarios involving exposure to potent synthetic opioids and corrosive substances (ASTM D5151 and ASTM F1671).

· Successful permeation testing for both fentanyl citrate and simulated gastric acid is required.

Vendor Narrative Response:

7. Have an FDA cleared labeling claim for low dermatitis potential (supported by clinical data and ISO 10993).

Vendor Narrative Response:

8. Maintain an Acceptable Quality Level (AQL) of 1.0 or better, exceeding typical industry thresholds to ensure superior defect control and reliable barrier reliability in diverse medical settings (ASTM D5151).

Vendor Narrative Response:

8. Possess FDA Class I reserved medical device status with active 510(k) clearance demonstrating equivalency and compliance with federal performance and safety requirements.

Vendor Narrative Response:

9. Nitrile Exam Gloves shall not be black in color for medical treatment facility use. Acceptable glove colors include, but are not limited to, grey blue, and lavender.

· Lighter glove colors are preferred as they provide greater visual contrast with blood and body fluids. Documentation shall confirm either:

i. The glove color was cleared in the 510(k); or

ii. The color change did not require a new 510(k) because it was tested and did not constitute a material change.

Vendor Narrative Response:

Other Requested Information:

1. If domestic manufacturing does not exist, identify a specific manufacturing facility location that can establish the required domestic manufacturing for nitrile exam gloves and identify the timeframe for commencing domestic manufacturing providing specific approvals and contingencies, if applicable.

Vendor Narrative Response:

2. If the respondent has partnered with a US-Manufacturer to produce a nitrile exam glove meeting the minimum requirements stated above, provide the partner’s name, address, point of contact, and indicate whether a signed letter of commitment is in place.

Vendor Narrative Response:

3. Identify the Country of origin for the Nitrile Butadiene Rubber (NBR).

Vendor Response:

4. Identify manufacturing capacity and lead times of the respondent or its partner.

Vendor Narrative Response:

5. Explain how the glove is dispensed from the box. Does the box allow for a single-glove withdrawal, prevent multiple gloves from dispensing at once, or any other means of minimizing cross contamination? Explain if/how the box minimizes cross contamination by controlling dispensing and reducing waste. The dispensing method should support established infection‑control best practices.

Vendor Narrative Response:

6. Any additional relevant product or capability information including the file names of all attachments your company is providing the Government in response to the RFI.

Vendor Narrative Response: