FDA Product Code LYU: Accessory, Surgical Apparel
Leading manufacturers include Instrument Makar, Inc., Sloan Corp. and American Medical Mfg., Inc..
56
Total
56
Cleared
181d
Avg days
1988
Since
FDA 510(k) Cleared Accessory, Surgical Apparel Devices (Product Code LYU)
56 devices
Cleared
Jun 22, 2001
STRYKER T4 HYTREL (R) TOGAS
Stryker Corp.
General Hospital
16d
Cleared
Aug 27, 1997
NURSES BOUFFANT CAP
Copioumed Intl., Inc.
General Hospital
239d
Cleared
Jul 10, 1997
FAR-EAST BOUFFANT CAPS
Far East Science & Technology Development Co., Ltd.
General Hospital
114d
Cleared
Feb 25, 1997
DISPOSABLE APRON
Instrument Makar, Inc.
General Hospital
116d
Cleared
Aug 09, 1996
DEPUY DISPOSABLE FILTER/HOOD
Depuy, Inc.
General Hospital
92d
Cleared
Jul 25, 1996
AMMI MAGNI-GUARD
American Medical Mfg., Inc.
General Hospital
101d
Cleared
Mar 19, 1996
SLOAN STA-DRI PANT PROTECTOR
Sloan Corp.
General Hospital
567d
Cleared
Aug 07, 1995
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
Thantex Specialties, Inc.
General Hospital
459d
Cleared
Feb 23, 1995
MAKAR FULL AND HALF FACE SHIELD
Instrument Makar, Inc.
General Hospital
254d
Cleared
Jul 08, 1994
FACE-IT SHIELD
Onyx Medical Corp.
General Hospital
73d
Cleared
Mar 09, 1994
TECNOL SPLASHGUARD
Tecnol Medical Products, Inc.
General Hospital
152d
Cleared
Feb 14, 1994
PROCEL(TM) DERMALINER GLOVE
W.L. Gore & Associates, Inc.
General Hospital
348d
Cleared
Jul 09, 1993
ULTRATUFF CUT RESISTANT GLOVE LINER
Baxter Healthcare Corp
General Hospital
245d
Cleared
Oct 15, 1992
GUARDALL SHIELD
Anago, Inc.
General Hospital
321d
Cleared
Jul 27, 1990
CUT RESISTANT GLOVE LINER
Biomet, Inc.
General Hospital
43d
Cleared
Aug 11, 1989
STERILE HAND COVER
Sage Products, Inc.
General Hospital
64d