| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
054
|
Date of Entry 07/06/2020
|
|
FR Recognition Number
|
6-443
|
| Standard | |
ASTM D3577-19
Standard Specification for Rubber Surgical Gloves |
|
Scope/Abstract1.1 This specification covers certain requirements for packaged sterile rubber surgical gloves used in conducting surgical procedures.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 The following safety hazards caveat pertains only to the test method portion, Section 8, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. |
|
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 |
| §878.4460 |
Surgeon'S Gloves
|
Class 1
|
KGO
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for 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
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
