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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 9-111
Standard
ISO 4074 Third edition 2015-10-15
Natural latex rubber condoms - Requirements and test methods
Scope/Abstract
ISO 4074:2015 specifies requirements and test methods for male condoms made from natural rubber latex.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§884.5310 Condom With Nonoxynol-9 Class 2 LTZ
§884.5300 Condom Class 2 HIS
21 CFR 801.435, User labeling for latex condoms
Relevant FDA Guidance and/or Supportive Publications
Latex Condoms for Men: Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions, Issued July 1998.

Guidance for Industry and FDA Staff: Surveillance and Detention without Physical Examination of Condoms, Issued July 2008.

Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300, Issued December 2008.

Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide, Issued January 2009.

Guidance for Industry: User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide, Issued April 2003.
FDA Technical Contact
 Sharon Andrews
  FDA/OMPT/CDRH/ODE/DRGUD/OGDB/
  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
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