Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-112: AAMI / ANSI PB70:2003/(R)2009, 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: 2009. |
| Addresses of Standards 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: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
|
| (2) | OFFICE OF COMPLIANCE (OC) | | |
|
|
| 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: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §878.4040 |
Gown, Surgical |
Class 2 |
FYA |
| |
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 (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 |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2502 |
| Silver Spring MD 20993 |
| 301/796-6299 |
| Email: terrell.cunningham@fda.hhs.gov |
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