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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Keyword: gown
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(click for recognition information)
 
07/09/2014 Sterility 14-286 Complete ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
12/22/2025 General Plastic Surgery/
General Hospital		 6-520 Complete ASTM F3352/F3352M-23b Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
12/22/2025 General Plastic Surgery/
General Hospital		 6-518 Complete ASTM F1670/F1670M-24a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
12/22/2025 General Plastic Surgery/
General Hospital		 6-516 Partial ASTM F2407/F2407M-23a Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
05/29/2023 General Plastic Surgery/
General Hospital		 6-496 Partial ASTM F739-20 Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
05/29/2023 General Plastic Surgery/
General Hospital		 6-494 Complete ASTM F3352/F3352M-23a Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
05/29/2023 General Plastic Surgery/
General Hospital		 6-491 Complete ASTM F1670/F1670M-17a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
05/29/2023 General Plastic Surgery/
General Hospital		 6-488 Complete ASTM F1671/F1671M-22 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
05/29/2023 General Plastic Surgery/
General Hospital		 6-487 Partial ANSI AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
12/21/2020 General Plastic Surgery/
General Hospital		 6-448 Partial ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
 
 
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