| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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054
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Date of Entry 07/06/2020
|
|
FR Recognition Number
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6-178
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| Standard | |
ASTM D6124-06(2022)
Standard Test Method for Residual Powder on Medical Gloves |
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Scope/Abstract1.1 This test method covers the determination of average powder or filter-retained mass found on a sample of medical gloves as described in the introduction.
1.2 The average powder mass per glove is reported in milligrams.
1.3 The safe and proper use of medical gloves is beyond the scope of this test method.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. |
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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. |
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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:
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. |
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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 |
Vinyl Patient Examination Glove
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Class 1
|
LYZ
|
| §880.6250 |
Polymer Patient Examination Glove
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Class 1
|
LZA
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA - Medical Glove Guidance Manual, Issued January 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
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
