LYU · Class I · 21 CFR 878.4040

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
1–24 of 56
Cleared Jun 22, 2001
STRYKER T4 HYTREL (R) TOGAS
K011755
Stryker Corp.
General Hospital · 16d
Cleared Aug 27, 1997
NURSES BOUFFANT CAP
K965237
Copioumed Intl., Inc.
General Hospital · 239d
Cleared Jul 10, 1997
FAR-EAST BOUFFANT CAPS
K970988
Far East Science & Technology Development Co., Ltd.
General Hospital · 114d
Cleared Feb 25, 1997
DISPOSABLE APRON
K964364
Instrument Makar, Inc.
General Hospital · 116d
Cleared Aug 09, 1996
DEPUY DISPOSABLE FILTER/HOOD
K961791
Depuy, Inc.
General Hospital · 92d
Cleared Jul 25, 1996
AMMI MAGNI-GUARD
K961454
American Medical Mfg., Inc.
General Hospital · 101d
Cleared Mar 19, 1996
SLOAN STA-DRI PANT PROTECTOR
K945302
Sloan Corp.
General Hospital · 567d
Cleared Aug 07, 1995
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
K942200
Thantex Specialties, Inc.
General Hospital · 459d
Cleared Feb 23, 1995
MAKAR FULL AND HALF FACE SHIELD
K942828
Instrument Makar, Inc.
General Hospital · 254d
Cleared Jul 08, 1994
FACE-IT SHIELD
K942022
Onyx Medical Corp.
General Hospital · 73d
Cleared Mar 09, 1994
TECNOL SPLASHGUARD
K934842
Tecnol Medical Products, Inc.
General Hospital · 152d
Cleared Feb 14, 1994
PROCEL(TM) DERMALINER GLOVE
K931094
W.L. Gore & Associates, Inc.
General Hospital · 348d
Cleared Jul 09, 1993
ULTRATUFF CUT RESISTANT GLOVE LINER
K925628
Baxter Healthcare Corp
General Hospital · 245d
Cleared Oct 15, 1992
GUARDALL SHIELD
K915415
Anago, Inc.
General Hospital · 321d
Cleared Jul 27, 1990
CUT RESISTANT GLOVE LINER
K902633
Biomet, Inc.
General Hospital · 43d
Cleared Aug 11, 1989
STERILE HAND COVER
K894064
Sage Products, Inc.
General Hospital · 64d

About Product Code LYU - Regulatory Context