Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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6-444
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Standard | |
ASTM D7103-19(2023) Standard Guide for Assessment of Medical Gloves |
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Scope/Abstract1.1 This guide is intended to assist in the identification and application of the most appropriate ASTM and associated standards for the assessment, development of specifications, and selection of medical gloves with the ultimate goal of maintaining the safety and health of healthcare workers who may come into contact with biological and chemical hazards. 1.2 No guidance document or assessment protocol can ensure the selection of medical gloves that guarantees healthcare worker protection. The purpose of testing and assessing medical gloves is to generate the performance data and quality information that will allow the most appropriate assessment and selection of medical gloves. Ultimately, the selection of medical gloves shall be based on the evaluation of available technical data, quality information, and professional assessment of risk. 1.3 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. |
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Extent of Recognition
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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
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Class 1
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KGO
|
§880.6250 |
Latex Patient Examination Glove
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Class 1
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LYY
|
§880.6250 |
Vinyl Patient Examination Glove
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Class 1
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LYZ
|
§880.6250 |
Polymer Patient Examination Glove
|
Class 1
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LZA
|
§880.6250 |
Finger Cot
|
Class 1
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LZB
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800.20 Patient examination gloves and surgeons gloves; sample plans and test method for leakage defects; a |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Medical Glove Guidance Manual, 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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
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*These are provided as examples and others may be applicable. |