Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 6-440
Standard
ASTM  D3578-19(2023)
Standard Specification for Rubber Examination Gloves
Scope/Abstract
1.1 This specification covers certain requirements for natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material.
1.2 This specification provides for natural rubber gloves that fit either hand, paired gloves, and gloves by . It also provides for packaged sterile natural rubber gloves and packaged or bulk nonsterile natural rubber gloves.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
All text related to Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove.
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.

This standard is recognized in part because:
The Food and Drug Administration (FDA) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.

The FDA does not recognize this/these clause(s) in this standard because Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. See Final Rule below.
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
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance of Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008.

2. Final Rule: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans.

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
 Bifeng Qian
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-2261
  Bifeng.Qian@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
-
-