| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
051
|
Date of Entry 01/14/2019
|
|
FR Recognition Number
|
6-338
|
| Standard | |
ASTM D7866-14
Standard Specification for Radiation Attenuating Protective Gloves |
|
Scope/Abstract| 1.1 To describe the requirements for packaged protective gloves with radiation attenuating properties intended to protect the operator or other persons from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Minimum attenuation values will be defined. |
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| 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. |
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Transition Period
| FDA recognition of ASTM D7866-14 [Rec# 6-338] will be superseded by recognition of ASTM D7866-23 [Rec# 6-497]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-338] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 6-338] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §878.4460 |
Surgeon'S Gloves
|
Class 1
|
KGO
|
| §880.6250 |
Latex Patient Examination Glove
|
Class 1
|
LYY
|
| §880.6250 |
Polymer Patient Examination Glove
|
Class 1
|
LZA
|
| §892.6500 |
Radiographic Protective Glove
|
Class 1
|
IWP
|
|
Relevant FDA Guidance and/or Supportive Publications*
Medical Glove Guidance Manual - Guidance for Industry and FDA Staff, Issued 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 Contact
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
