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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 5-62: ANSI / ASQ Z1.4-2008, sampling procedures and tables for inspection by attributes. (General I (QS/RM))

Date of Standard: 2008. 
Addresses of Standards Development Organizations:
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
 American Society for Quality (ASQ)
  600 North Plankinton Avenue
  Milwaukee, WI 53203
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
All Medical Devices
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 National, Horizontal
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 Latex Patient Examination Glove Class 1 LYY
§880.6250 Patient Examination Glove Class 1 FMC
§880.6250 Polymer Patient Examination Glove Class 1 LZA
§880.6250 Vinyl Patient Examination Glove Class 1 LYZ
§884.5300 Condom Class 2 HIS
§884.5300 Condom, Synthetic Class 2 MOL
§884.5310 Condom With Nonoxynol-9 Class 2 LTZ
FDA Technical Contact:
 William MacFarland
  FDA/CDRH/OC
  10903 New Hampshire Avenue Building 66, Room 1108
  Silver Spring MD 20993
  301/796-5547
  email: william.macfarland@fda.hhs.gov
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