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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Recognition 06/27/2016 
FR Recognition Number 6-183
Standard
ASTM D5250-06 (Reapproved 2015)
Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
Scope/Abstract
1.1 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.

1.2 This specification provides for poly(vinyl chloride) gloves that fit either hand, paired gloves, and gloves by . It also provides for packaged sterile or nonsterile or bulk nonsterile poly(vinyl chloride) gloves.

1.3 This specification does not cover two-dimensional heat sealed poly(vinyl chloride) gloves.

1.4 This specification is similar to that of Specification D3578 for rubber examination gloves.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§880.6250 Polymer Patient Examination Glove Class 1 LZA
§880.6250 Vinyl Patient Examination Glove Class 1 LYZ
Relevant FDA Guidance and/or Supportive Publications
Guidance of Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008.

Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff, Issued December 2, 2014.
FDA Technical Contact
 John Stansberry
  FDA/OMPT/CDRH/ODE/DAGID/INCB
  240-402-8915
  John.Stansberry@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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