| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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055
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Date of Entry 12/21/2020
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FR Recognition Number
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6-448
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| Standard | |
ASTM F2407-20
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
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Scope/Abstract1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. Four levels of barrier properties for surgical gowns are specified in ANSI/AAMI PB70 and are included in this specification for reference purposes.
Note 1-Some properties require minimum performance and others are for documentation only.
Note 2-ANSI/AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown.
1.2 This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products.
1.3 This specification is not intended to serve as a detailed manufacturing or purchase specification, but can be referenced in purchase specifications as the basis for selecting test requirements.
1.4 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 1 Scope
Clause 6.1 Biocompatibility
Clause 9.4 Sterilization |
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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.
Clause 1 is inconsistent with the existing published FDA guidance #2 listed below (See Section IV Policy).
Clause 6.1 is inconsistent with the existing published FDA guidance #3 listed below (See Attachment A: Evaluation Endpoints for Consideration).
Clause 9.4 is inconsistent with the existing published FDA guidance #4 listed below (See Section VI FDA's Six Criteria for Reprocessing Instructions). |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §878.4040 |
Gown, Surgical
|
Class 2
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FYA
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| §878.4040 |
Gown, Isolation, Surgical
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Class 2
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FYC
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, Issued August 1993.
2. Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - Guidance for Industry and Food and Drug Administration Staff, Document issued on December 9, 2015.
3. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff, Document issued on September 4, 2020.
4. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Document issued on March 17, 2015 and Appendix E of this guidance was updated on June 9, 2017.
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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| 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. |
