Standard Organization:

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

Recognition Date2013-08-06
Recognition List031
Recognition Number6-296
Extent Complete standard
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STG General Plastic Surgery/General Hospital
FDA Tech  Elizabeth Claverie   FDA/OMPT/CDRH/ODE/DAGID/INCB/   301-796-6298


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 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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§878.4370 Cover, Barrier, Protective Class 2 MMP
§878.4370 Drape, Microscope, Ophthalmic Class 2 HMW
§878.4370 Drape, Patient, Ophthalmic Class 2 HMT
§878.4370 Drape, Pure Latex Sheet, With Self-Retaining Finger Cot Class 2 EYX
§878.4370 Drape, Surgical Class 2 KKX
§878.4370 Drape, Surgical, Ent Class 2 ERY
§878.4370 Drape, Urological, Disposable Class 2 EYY
§878.4370 General Surgery Tray Class 2 LRO
§878.4370 Pad, Kelly Class 2 FNW
§878.4370 Ring (Wound Protector), Drape Retention, Internal Class 2 KGW
§878.4040 Gown, Surgical Class 2 FYA

FDA Guidance:

Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes. Issued August 1993

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