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ASTM D3577 - 19(2023)
ASTM International (ASTM)
Title

"Standard Specification for Rubber Surgical Gloves"

Description

This specification covers certain requirements for packaged sterile rubber surgical gloves used in conducting surgical procedures.

Standard Type(s)
Specification

An explicit set of requirements to be satisfied by a material, product, system, or service: Examples of specifications include, but are not limited to, requirements for; physical, mechanical, or chemical properties, and safety, quality, or performance criteria. A specification identifies the test methods for determining whether each of the requirements is satisfied.

Personal Protective Equipment
Hand and Arm Protection

All equipment and/or accessories (whether or not detachable) designed and manufactured specifically to protect the arm and/or the hand this includes all garments protecting the hand or part of the hand, including gloves, fingerless gloves, mittens, garments protecting the fingers only or the palm only, etc. Potential hazards include skin absorption of harmful substances, chemical or thermal burns, electrical dangers, bruises, abrasions, cuts, punctures, fractures and amputations.

  • Medical gloves
Hazards
Biological
  • Biological
SOC Codes
29-0000 Healthcare Practitioners and Technical Occupations
  • 29-9000 Other Healthcare Practitioners and Technical Occupations
    • 29-9010 Occupational Health and Safety Specialists and Technicians
Standard References
Test Method

ASTM D5151 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD515119(2023)) - Standard Test method for detection of holes in medical gloves

ASTM D5712 - 15(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD571215(2020)) - Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method

Referenced Standard

ASTM D6124 - 06(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD612406(2022)) - Standard Test Method for Residual Powder on Medical Gloves

Conformity Assessment Notes

Set of requirements to be satisfied, please see the full standard for complete details.

Comments

Additional References:

ASTM Standards

  • D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension
  • D573 Test Method for Rubber--Deterioration in an Air Oven
  • D3767 Practice for Rubber--Measurement of Dimensions
  • D5151 Test Method for Detection of Holes in Medical Gloves
  • D5712 Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
  • D6124 Test Method for Residual Powder on Medical Gloves
  • D6499 Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products Includes performance criteria. 

ISO Standards

  • ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
Testing Laboratories
Intertek - Cortland, NY, 13045
Contact

Phone Number: (607) 753-6711
Email: jason.allen@intertek.com

Accreditations

ISO 17025

Scope of Accreditation

ANSI/ISEA Z87.1-2020(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/ISEAZ8712020) , ASTM F2412 - 18a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF241218a) , ASTM D120 - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD12022) , ASTM D3577 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357719(2023)) , ASTM D3578 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357819(2023)) , ASTM D5250 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD525019(2023)) , ASTM D5712 - 15(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD571215(2020)) , ASTM D6319 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD631919(2023)) , ASTM D6978 - 05(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD697805(2023)) , ASTM D7246 - 06(2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD724606(2021)) , ASTM F1446 - 20(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF144620) , ANSI/AAMI PB70:2022(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70%3a2022) , ASTM F1342 / F1342M - 05(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1342/F1342M05(2022)) , ASTM F1359 / F1359M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1359/F1359M22) , ASTM F1670 / F1670M - 17a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1670/F1670M17a) , ASTM F1671 / F1671M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1671/F1671M22) , ASTM F1790 / F1790M - 15 (Reapproved 2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1790/F1790M15(Reapproved2021)) , ASTM F2588 - 12(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF258812(2020)) , ASTM F739 - 20(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF73920) , ASTM F903 - 18(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF90318) , ASTM F1862 / F1862M - 17(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1862/F1862M17) , ASTM F2100 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210023) , ASTM F2101 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210123) , ASTM F2299 / F2299M - 24(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF2299/F2299M24) , ANSI/AAMI PB70 - Class 4(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class4) , ANSI/AAMI PB70 - Class 3(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3)

Akron Rubber Development Laboratory, Inc. - Akron, OH, 44322-1016
Notes

Accredited Gloves Testing Methods ASTM Testing Methods

  •  ASTM D6319 - Standard Specification for Nitrile Examination Gloves for Medical Application
  • ASTM D6978 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
  • ASTM D7558 - Colorimetric/Spectrophotometric Procedure to Quantify Extractable Chemical Dialkyldithiocarbamate, Thiuram and Mercaptobenzothiazole Accelerators in Natural Rubber Latex and Nitrile Gloves
  • ASTM D120 — Standard Specification for Rubber Insulating Gloves
  • ASTM D3577 — Standard Specification for Rubber Surgical Gloves
  • ASTM D3578 — Standard Specification for Rubber Examination Gloves
  • ASTM D5151 — Standard Test Method for Detection of Holes in Medical Gloves
  • ASTM D6124 — Standard Test Method for Residual Powder on Medical Gloves
  • ASTM D5250 - Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application
  • ARDL 2140 - Lubricant Compatibility Testing on Gloves
  • ASTM D5712 - Analysis of Aqueous Extractable Protein in Latex, Natural Robber and Elastomeric Products Using the Modified Lowry Method
  • ASTM D6499 - Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products
  • ASTM F739 — Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
  • ASTM F1383 - Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Intermittent Contact
  • ASTM F1670 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
  • ASTM F1671/F1671M — 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
  • ASTM F903 — Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquids
  • ASTM E96/E96M Water Vapor Transmission of Materials
  • ASTM D6977 — Standard Specification for Polychloroprene Examination Gloves for medical Application
  • ASTM D7246 — Standard Test Method for Detection of Holes in Polyethylene Food Service Gloves
  • ASTM D7329 — Standard Specification for Food Preparation and Food Handling Glove

The following link points to ARDL's searchable ISO 17025 Scope of Accreditations: 

https://www.ardl.com/sites/default/files/assets/scope-as-of-8-30-22.pdf
Contact

Phone Number: (330) 794-6600
Email: answers@ardl.com

Accreditations

ISO 17025

Scope of Accreditation

ASTM D120 - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD12022) , ASTM D3577 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357719(2023)) , ASTM D3578 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357819(2023)) , ASTM D5151 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD515119(2023)) , ASTM D5250 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD525019(2023)) , ASTM D5712 - 15(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD571215(2020)) , ASTM D6124 - 06(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD612406(2022)) , ASTM D6319 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD631919(2023)) , ASTM D6978 - 05(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD697805(2023)) , ASTM D7246 - 06(2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD724606(2021)) , ANSI/AAMI PB70:2022(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70%3a2022) , ASTM F1342 / F1342M - 05(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1342/F1342M05(2022)) , ASTM F1383 - 20(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF138320) , ASTM F1670 / F1670M - 17a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1670/F1670M17a) , ASTM F1671 / F1671M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1671/F1671M22) , ASTM F739 - 20(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF73920) , ASTM F903 - 18(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF90318) , ANSI/AAMI PB70 - Class 4(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class4) , ANSI/AAMI PB70 - Class 3(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3)

Nelson Laboratories, Inc. - Salt Lake City, UT, 84123
Notes

FDA Registered and ANSI-ASQ National Accreditation Board/ACLASS
Contact

Phone Number: (801) 290-7500
Email: sdrosner@nelsonlabs.com

Accreditations

ISO 17025

Scope of Accreditation

ASTM D120 - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD12022) , ASTM D3577 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357719(2023)) , ASTM D3578 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357819(2023)) , ASTM D5151 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD515119(2023)) , ASTM D5250 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD525019(2023)) , ASTM D5712 - 15(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD571215(2020)) , ASTM D6124 - 06(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD612406(2022)) , ASTM D6319 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD631919(2023)) , ASTM D6978 - 05(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD697805(2023)) , ASTM D7246 - 06(2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD724606(2021)) , ANSI/AAMI PB70:2022(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70%3a2022) , ASTM F1342 / F1342M - 05(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1342/F1342M05(2022)) , ASTM F1670 / F1670M - 17a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1670/F1670M17a) , ASTM F1671 / F1671M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1671/F1671M22) , ASTM F903 - 18(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF90318) , ASTM F1862 / F1862M - 17(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1862/F1862M17) , ASTM F2100 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210023) , ASTM F2101 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210123) , ASTM F1819 - 19(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF181919) , ANSI/AAMI PB70 - Class 4(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class4) , ANSI/AAMI PB70 - Class 3(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3)

Vartest Laboratories, Inc. - New York, NY, 10018
Notes
Scope of Accreditation (A2LA):
Contact

Phone Number: (212) 947-8391
Email: avarley@vartest.com

Accreditations

ISO 17025

Scope of Accreditation

ASTM D3577 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357719(2023)) , ASTM D3578 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357819(2023)) , ASTM D5250 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD525019(2023)) , ASTM D6978 - 05(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD697805(2023)) , ASTM F1670 / F1670M - 17a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1670/F1670M17a) , ASTM F1671 / F1671M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1671/F1671M22) , ASTM F903 - 18(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF90318)

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