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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 6-145
Standard
ASTM D3578-05 (Reapproved 2015)
Standard Specification for Rubber Examination Gloves
Scope/Abstract
1.1 This specification covers certain requirements for natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material.

1.2 This specification provides for natural rubber gloves that fit either hand, paired gloves, and gloves by . It also provides for packaged sterile natural rubber gloves and packaged or bulk nonsterile natural rubber 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 Latex Patient Examination Glove Class 1 LYY
§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
FDA Technical Contact
 Bifeng Qian
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-2261
  bifeng.qian@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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