| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
040
|
Date of Entry 08/14/2015
|
|
FR Recognition Number
|
6-354
|
| Standard | |
ASTM D7907-14 (Reapproved 2019)
Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves |
|
Scope/Abstract1.1 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
|
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 |
Vinyl Patient Examination Glove
|
Class 1
|
LYZ
|
| §880.6250 |
Polymer Patient Examination Glove
|
Class 1
|
LZA
|
| §880.6250 |
Medical Glove, Specialty
|
Class 1
|
LZC
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Medical Glove Guidance Manual, January 2008
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 Contacts
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
