| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
061
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Date of Entry 12/18/2023
|
|
FR Recognition Number
|
6-497
|
| Standard | |
ASTM D7866-23
Standard Specification for Radiation Attenuating Protective Gloves |
|
Scope/Abstract| This specification describes the requirements for packaged, thin film medical 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. It specifies the minimum attenuation values and physical property requirements for these radiation-attenuating gloves, which must be compounded from natural rubber latex, rubber cement or synthetic polymers. This specification also covers labeling requirements. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Clause 5.1.1 Sample size |
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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:
Clause 5.1.1 does not establish a sample size based on risk assessment or statistical performance. The sample size was reduced from 13 gloves (ASTM D7866-14, see reference #1 below) to 2 gloves (ASTM D7866-23)). This is in conflict with FDA guidance (see reference #2 below, Section II.B.3.b) because the objective of the standard did not change and a risk analysis or other scientific evidence (e.g., scientific literature or interlaboratory study) was not included to support the sample size reduction. |
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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| FDA recognition of ASTM D7866-14 [Rec# 6-338] will be superseded by recognition of ASTM D7866-23 [Rec# 6-497].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
|
| §880.6250 |
Radiation Attenuating Medical Glove
|
Class 1
|
OPH
|
| §892.6500 |
Radiographic Protective Glove
|
Class 1
|
IWP
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. ASTM D7866-14 Standard Specification for Radiation Attenuating Protective Gloves.
2. Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff, issued December 2019.
3. 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. |
