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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 026 FR Publication Date: 03/18/2011 

Part B: Supplementary Information

Recognition Number 6-145: ASTM D3578-05 (Reapproved 2010), standard specification for rubber examination gloves. (General Plastic Surgery/General Hospital)

Date of Standard: 2005. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Rubber Examination Gloves
Processes Affected:
510(k)
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
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 Guidance:
Guidance of Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008
FDA Technical Contact:
 Donna L. Walsh
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2126
  Silver Spring MD 20993
  301/796-2498
  email: donna.walsh@fda.hhs.gov
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