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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 6-296: AAMI / ANSI PB70:2012, liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. (General Plastic Surgery/General Hospital)

Date of Standard: 2012. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
CDRH Offices and Divisions associated with recognized standards:
Devices Affected:
Surgical Gowns and Surgical Drapes
Processes Affected:
510(K), PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Device Name Device
§878.4040 Gown, Surgical Class 2 FYA
§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 (Kit) Class 2 LRO
§878.4370 Pad, Kelly Class 2 FNW
§878.4370 Ring (Wound Protector), Drape Retention, Internal Class 2 KGW
Relevant Guidance:
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes. Issued August 1993
FDA Technical Contact:
 Terrell Cunningham
  10903 New Hampshire Avenue Building 66, Room 2502
  Silver Spring MD 20993
  email: terrell.cunningham@fda.hhs.gov