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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 6-282: ASTM D6499-12, standard test method for the immunological measurement of antigenic protein in natural rubber and its products. (General Plastic Surgery/General Hospital)

Date of Standard: 2012. 
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:
Devices Affected:
Medical gloves and condoms made from natural rubber latex
Processes Affected:
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard. The specific review division should be contacted to inquire about using this standard to support labeling claims. See Relevant Guidance
Related CFR Citations and Product Codes:
Device Name Device
§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
  10903 New Hampshire Avenue Building 64, Room 4010
  Silver Spring MD 20993
  email: anne.lucas@fda.hhs.gov