| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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057
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Date of Entry 12/20/2021
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FR Recognition Number
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6-474
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| Standard | |
ASTM F3352-19
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
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Scope/Abstract1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes.
1.2 There are other types of gowns that are used in healthcare settings, including: cover gowns, procedure gowns, comfort gowns, precaution gowns, and open-back gowns. All gowns not meeting the definition of isolation gown in 3.1.7 as defined by ANSI/AAMI PB70 are excluded from this standard.
1.3 This specification does not address protective clothing used for surgical applications, such as surgical gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Subclause 4.3.2
Subclause 6.1 Biocompatibility
Clause 11 Labeling Requirements
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Rationale for Recognition
Subclause 4.3.2 and Subclause 6.1 (Biocompatibility) are in conflict with existing published FDA guidance (See Table A.1 of guidance #3 listed below).
Clause 11 (Labeling Requirements) is in conflict with existing published FDA guidance (See Section C.3 of guidance #1 listed below). |
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Transition Period
| FDA recognition of ASTM F3352-19 [Rec# 6-474] will be superseded by recognition of ASTM F3352/F3352M-23a [Rec# 6-494]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-474] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 6-474] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §878.4040 |
Gown, Isolation, Surgical
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Class 2
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FYC
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| §878.4040 |
Non-Surgical Gown
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Class 1
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OEA
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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, issued December 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, issued September 2020.
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. |
