Nitrile Exam Glove Request for Information Attachment 1

Nitrile Exam Glove Request for Information (RFI)
Attachment 1
Company name:
Business size:
Address:
Point of contact information:

Minimum Requirements:

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:

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:

Provide balanced durability tensile strength (ASTM D412), and tactile sensitivity (ASTM D3767) sufficient for sustained use in highvolume medical environments without tearing, excessive fatigue, or compromised performance. Vendor Narrative Response:

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:

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:

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

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).