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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Entry 01/27/2015 
FR Recognition Number 5-62
Standard
ANSI ASQ  Z1.4-2003 (R2018)
Sampling Procedures and Tables for Inspection by Attributes
Scope/Abstract
This publication establishes sampling plans and procedures for inspection by attributes. When specified by the responsible authority, this publication shall be referenced in the specification, contract, inspection instructions, or other documents and the provisions set forth herein shall govern. The "responsible authority" shall be designated in one of the above documents, as agreed to by the purchaser and seller or producer and user.
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
§878.4460 Surgeon'S Gloves Class 1 KGO
§880.6250 Patient Examination Glove Class 1 FMC
§880.6250 Latex Patient Examination Glove Class 1 LYY
§880.6250 Vinyl Patient Examination Glove Class 1 LYZ
§880.6250 Polymer Patient Examination Glove Class 1 LZA
§884.5300 Condom Class 2 HIS
§884.5300 Condom, Synthetic Class 2 MOL
§884.5310 Condom With Nonoxynol-9 Class 2 LTZ
Relevant FDA Guidance and/or Supportive Publications*
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
 William MacFarland
  FDA/OC/CDRH/OPEQ/OHTII/
  301-796-5547
  william.macfarland@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ASQ American Society for Quality https://asq.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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