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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 9-88
Standard
ISO 29942 First edition 2011-07-01
Prophylatic dams -- Requirements and test methods
Scope/Abstract
ISO 29942:2011 specifies the minimum requirements and test methods for prophylactic dams used to assist in the prevention of sexually transmitted infections.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§884.5300 Barrier, Std, Oral Sex Class 2 MSC
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry: User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide, Issued April 2003.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Sharon Andrews
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-6529
  sharon.andrews@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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