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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 6-176
Standard
ASTM D7103-06 (Reapproved 2013)
Standard Guide for Assessment of Medical Gloves
Scope/Abstract
1.1 This guide is intended to assist in the identification and application of the most appropriate ASTM and associated standards for the assessment, development of specifications, and selection of medical gloves with the ultimate goal of maintaining the safety and health of healthcare workers who may come into contact with biological and chemical hazards.

1.2 No guidance document or assessment protocol can ensure the selection of medical gloves that guarantees healthcare worker protection. The purpose of testing and assessing medical gloves is to generate the performance data and quality information that will allow the most appropriate assessment and selection of medical gloves. Ultimately, the selection of medical gloves shall be based on the evaluation of available technical data, quality information, and professional assessment of risk.

Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Section 10 "Assessment of Resistance to Viral Penetration"
Rationale for Recognition
Conflicts with an existing regulation.

Section 10: Assessment of Resistance to Viral Penetration is in conflict with an existing regulation. See section 21 CFR 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration. Subsection b)(1)(i) Units examined. Each medical glove will be analyzed independently. When packaged as pairs, each glove is considered separately, and both gloves will be analyzed.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§880.6250 Finger Cot Class 1 LZB
§880.6250 Latex Patient Examination Glove Class 1 LYY
§880.6250 Polymer Patient Examination Glove Class 1 LZA
§880.6250 Vinyl Patient Examination Glove Class 1 LYZ
§878.4460 Surgeon'S Gloves Class 1 KGO
800.20 Patient examination gloves and surgeons gloves; sample plans and test method for leakage defects; a
Relevant FDA Guidance and/or Supportive Publications
Medical Glove Guidance Manual - Guidance for Industry and FDA Staff, Issued January 2008.
FDA Technical Contact
 John Stansberry
  FDA/OMPT/CDRH/ODE/DAGID/INCB
  240-402-8915
  John.Stansberry@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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