Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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031
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Date of Entry 08/06/2013
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FR Recognition Number
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6-296
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Standard | |
ANSI AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
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Scope/AbstractThis standard establishes a system of classification for protective apparel and drapes used in healthcare facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance. The standard is intended to ultimately assist end-users in determining the type(s) of protective product most appropriate for a particular task or situation. |
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Extent of Recognition
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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. |
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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FDA recognition of ANSI, AAMI PB70:2012 [Rec# 6-296] will be superseded by recognition of ANSI, AAMI PB70:2022 [Rec# 6-487].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
|
Class 2
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FYA
|
§878.4370 |
Drape, Surgical, Ent
|
Class 2
|
ERY
|
§878.4370 |
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
|
Class 2
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EYX
|
§878.4370 |
Drape, Urological, Disposable
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Class 2
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EYY
|
§878.4370 |
Pad, Kelly
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Class 2
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FNW
|
§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
|
§878.4370 |
Ring (Wound Protector), Drape Retention, Internal
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Class 2
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KGW
|
§878.4370 |
Drape, Surgical
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Class 2
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KKX
|
§878.4370 |
General Surgery Tray
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Class 2
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LRO
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§878.4370 |
Cover, Barrier, Protective
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Class 2
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MMP
|
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Relevant FDA Guidance and/or Supportive Publications*
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes. Issued August 1993
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 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. |