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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 6-354
Standard
ASTM D7907-14
Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
Scope/Abstract
1.1 The methods herein specify two analytical tests for quantitatively evaluating surface bactericidal efficacy of medical examination gloves incorporated with bactericidal properties. They may be used for the determination of bactericidal activity on either the outer or inner glove surface. The methods incorporate bacterial challenges in two different formats: Method (A) a saline or buffered saline solution, and Method (B) a saline or buffered saline solution containing an organic load. Each method represents a different means of microbial contamination that can be expected in the healthcare environment.

1.2 Methods described herein are not appropriate for virucidal, fungicidal, tuberculocidal or sporicidal evaluations as each of these categories require unique culture techniques and testing conditions. Results of the test methods described in this document are limited to bactericidal efficacy against vegetative bacteria.

1.3 A more expansive glove description, such as broad spectrum antimicrobial efficacy, would require testing of a broader list of microbial species than vegetative bacteria alone. It is recommended that interested manufacturers discuss species and strain selections with appropriate regulatory agencies before testing is commenced.

1.4 Testing is to be performed by individuals trained in microbiological techniques under appropriate controlled conditions to ensure integrity of results and personnel safety.

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
§880.6250 Latex Patient Examination Glove Class 1 LYY
§880.6250 Patient Examination Glove, Specialty Class 1 LZC
§880.6250 Polymer Patient Examination Glove Class 1 LZA
§880.6250 Vinyl Patient Examination Glove Class 1 LYZ
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff Medical Glove Guidance Manual, January 2008
FDA Technical Contacts
 Ramesh K. Panguluri
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-6303
  ramesh.panguluri@fda.hhs.gov
 Katharine Segars
  FDA/OMPT/CDRH/ODE/DAGID/INCB
  240-402-2780
  Katharine.Segars@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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