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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 6-214: ASTM D6355-07 (Reapproved 2012), standard test method for human repeat insult patch testing of medical gloves. (General Plastic Surgery/General Hospital)

Date of Standard: 2007. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Medical gloves and condoms made from natural rubber latex
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
§878.4460 Surgeon'S Gloves Class 1 KGO
§880.6250 Finger Cot Class 1 LZB
§880.6250 Latex Patient Examination Glove Class 1 LYY
§880.6250 Patient Examination Glove, Specialty Class 1 LZC
§884.5300 Condom Class 2 HIS
Relevant Guidance:
Guidance for Industry and FDA Staff - Medical Glove Guidance Manual. Issued January 22, 2008

Latex Condoms for Men - Information for 510(k) Premarket Notification: Use of Consensus Standards for Abbreviated Submissions (July 23, 1998)

Compliance Policy Guide and FDA Test Methods (Sub Chapter 345 Obstetrics and Gynecology (Sec. 345.100 (CPG 7124.21))
FDA Technical Contact:
 Anne D. Lucas
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 64, Room 4010
  Silver Spring MD 20993
  301/796-0283
  email: anne.lucas@fda.hhs.gov
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