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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 021 FR Publication Date: 03/18/2009 

Part B: Supplementary Information

Recognition Number 6-215: ASTM F 2132 -01 (Reapproved 2008)e1, standard specification for puncture resistance of materials used in containers for discarded medical needles and other sharps. (General Plastic Surgery/General Hospital)

Date of Standard: 2008. 
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:
Sharps Dispoal Containers
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
§880.5570 Container, Sharps Class 2 MMK
Relevant Guidance:
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers, Issued October 1993
FDA Technical Contact:
 Elaine Mayhall, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2612
  Silver Spring MD 20993
  301/796-6301
  email: elaine.mayhall@fda.hhs.gov
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