| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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6-487
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| Standard | |
ANSI AAMI PB70:2022
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
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Scope/Abstract| Establishes minimum barrier performance requirements, a classification system, and associated labeling requirements for protective apparel, surgical drapes, and drape accessories intended for use in health care facilities. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
3 Definitions, Procedure gown
4.1 Labeling
Annex B (Informative) Examples of barrier performance classification of surgical gowns, surgical gowns-E, isolation gowns, other protective gowns, surgical drapes, hoods, togas, and other protective apparel |
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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:
3 Definitions "Procedure gown" is in conflict with existing regulations, 21 CFR 878.4040 and the guidance listed below (Ref (2)). FDA considers procedure gowns that claim moderate to high barrier penetration to be "surgical gowns" within the meaning of 21 CFR 878.4040.
4.1 Labeling is in conflict with 21 CFR 810.5(a) and final FDA Guidance (Ref (2)), which states that the level of liquid barrier protection must be clearly identified in labeling.
Annex B (informative), Examples of barrier performance classification of surgical gowns, surgical gowns-E, isolation gowns, other protective gowns, surgical drapes, hoods, togas, and other protective apparel", Figure B.2, "Example of a surgical gown-E intended for surgical applications" is in conflict with the published FDA Medical Gown website (Ref (3)), Surgical Gowns, Figure 1,"Critical Zones for Surgical Gowns." |
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Transition Period
| FDA recognition of ANSI, AAMI PB70:2012 [Rec# 6-296] will be superseded by recognition of ANSI, AAMI PB70:2022 [Rec# 6-487]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-296] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 6-296] 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, Surgical
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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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| §878.4040 |
Non-Surgical Gown
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Class 1
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OEA
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| §878.4040 |
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
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Class 2
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QPC
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| §878.4040 |
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
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Class 2
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QSO
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| §878.4370 |
Drape, Surgical, Ent
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Class 2
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ERY
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| §878.4370 |
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
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Class 2
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EYX
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| §878.4370 |
Drape, Urological, Disposable
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Class 2
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EYY
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| §878.4370 |
Pad, Kelly
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Class 2
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FNW
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| §878.4370 |
Drape, Patient, Ophthalmic
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Class 2
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HMT
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| §878.4370 |
Drape, Microscope, Ophthalmic
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Class 2
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HMW
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| §878.4370 |
Ring (Wound Protector), Drape Retention, Internal
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Class 2
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KGW
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| §878.4370 |
Drape, Surgical
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Class 2
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KKX
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| §878.4370 |
General Surgery Tray
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Class 2
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LRO
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| §878.4380 |
Drape, Adhesive, Aerosol
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Class 1
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KGT
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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) Medical Gowns. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns.
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 Organizations
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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. |
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