"Standard Specification for poly(vinyl chloride) gloves for medical application"
This specification covers certain requirements for poly- (vinyl chloride) gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers poly(vinyl chloride) gloves used in handling contaminated medical material.
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.
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
- Biological
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29-1000 Health Diagnosing and Treating Practitioners
- 29-1062 General Practitioners
ASTM D3578 - 19(2023) - Standard Specification for Rubber Examination Gloves
ASTM D5151 - 19(2023) - Standard Test method for detection of holes in medical gloves
ASTM D6124 - 06(2022) - Standard Test Method for Residual Powder on Medical Gloves
The specification is intended as a referee procedure for evaluating the performance and safety of poly(vinyl chloride) examination gloves. Set of requirements to be satisfied, please see the full standard for complete details.
Additional References:
ASTM Standards
- D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
- D573 Test Method for Rubber—Deterioration in an Air Oven
- D3578 Specification for Rubber Examination Gloves
- D3767 Practice for Rubber—Measurement of Dimensions
- D5151 Test Method for Detection of Holes in Medical Gloves
- D6124 Test Method for Residual Powder on Medical Gloves
ISO Standards
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
ICS Laboratories, Inc - Brunswic, OH, 44212 |
Notes |
A2LA ISO/IEC 17025 |
Contact |
Phone Number: (330) 220-0515 |
Accreditations |
Scope of Accreditation |
ANSI/ISEA Z87.1-2020 , ASTM D120 - 22 , ASTM D5250 - 19(2023) , ASTM D6978 - 05(2023) , ASTM D7246 - 06(2021) , ASTM F1446 - 20 , ASTM F1383 - 20 , ASTM F1407 - 12(2017) , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F739 - 20 , ASTM F903 - 18 |
Intertek - Cortland, NY, 13045 |
Contact |
Phone Number: (607) 753-6711 |
Accreditations |
Scope of Accreditation |
ANSI/ISEA Z87.1-2020 , ASTM F2412 - 18a , ASTM D120 - 22 , ASTM D3577 - 19(2023) , ASTM D3578 - 19(2023) , ASTM D5250 - 19(2023) , ASTM D5712 - 15(2020) , ASTM D6319 - 19(2023) , ASTM D6978 - 05(2023) , ASTM D7246 - 06(2021) , ASTM F1446 - 20 , ANSI/AAMI PB70:2022 , ASTM F1342 / F1342M - 05(2022) , ASTM F1359 / F1359M - 22 , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F1790 / F1790M - 15 (Reapproved 2021) , ASTM F2588 - 12(2020) , ASTM F739 - 20 , ASTM F903 - 18 , ASTM F1862 / F1862M - 17 , ASTM F2100 - 23 , ASTM F2101 - 23 , ASTM F2299 / F2299M - 24 , ANSI/AAMI PB70 - Class 4 , ANSI/AAMI PB70 - Class 3 |
Akron Rubber Development Laboratory, Inc. - Akron, OH, 44322-1016 |
Notes |
Accredited Gloves Testing Methods ASTM Testing Methods
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 |
Accreditations |
Scope of Accreditation |
ASTM D120 - 22 , ASTM D3577 - 19(2023) , ASTM D3578 - 19(2023) , ASTM D5151 - 19(2023) , ASTM D5250 - 19(2023) , ASTM D5712 - 15(2020) , ASTM D6124 - 06(2022) , ASTM D6319 - 19(2023) , ASTM D6978 - 05(2023) , ASTM D7246 - 06(2021) , ANSI/AAMI PB70:2022 , ASTM F1342 / F1342M - 05(2022) , ASTM F1383 - 20 , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F739 - 20 , ASTM F903 - 18 , ANSI/AAMI PB70 - Class 4 , ANSI/AAMI PB70 - Class 3 |
Nelson Laboratories, Inc. - Salt Lake City, UT, 84123 |
Notes |
FDA Registered and ANSI-ASQ National Accreditation Board/ACLASS |
Contact |
Phone Number: (801) 290-7500 |
Accreditations |
Scope of Accreditation |
ASTM D120 - 22 , ASTM D3577 - 19(2023) , ASTM D3578 - 19(2023) , ASTM D5151 - 19(2023) , ASTM D5250 - 19(2023) , ASTM D5712 - 15(2020) , ASTM D6124 - 06(2022) , ASTM D6319 - 19(2023) , ASTM D6978 - 05(2023) , ASTM D7246 - 06(2021) , ANSI/AAMI PB70:2022 , ASTM F1342 / F1342M - 05(2022) , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F903 - 18 , ASTM F1862 / F1862M - 17 , ASTM F2100 - 23 , ASTM F2101 - 23 , ASTM F1819 - 19 , ANSI/AAMI PB70 - Class 4 , ANSI/AAMI PB70 - Class 3 |
Vartest Laboratories, Inc. - New York, NY, 10018 |
Notes |
Scope of Accreditation (A2LA): |
Contact |
Phone Number: (212) 947-8391 |
Accreditations |
Scope of Accreditation |
ASTM D3577 - 19(2023) , ASTM D3578 - 19(2023) , ASTM D5250 - 19(2023) , ASTM D6978 - 05(2023) , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F903 - 18 |
- Page last reviewed: February 21, 2024
- Page last updated: February 21, 2024
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