LYU · Class I · 21 CFR 878.4040

FDA Product Code LYU: Accessory, Surgical Apparel

Leading manufacturers include Medical Armor Corp., Sloan Corp. and Wells Lamont Corp..

56
Total
56
Cleared
181d
Avg days
1988
Since
56 devices
25–48 of 56
Cleared Jun 24, 1994
DERMAL GLOVES
K932953
George Glove Company, Inc.
General Hospital · 372d
Cleared May 12, 1994
NYLON LINER GLOVES
K940274
Wells Lamont Corp.
General Hospital · 111d
Cleared Apr 20, 1994
KACEY DISPOSABLE GLOVE LINER
K935158
K & C Medical, Inc.
General Hospital · 174d
Cleared Apr 13, 1994
MOORE SECURE CAP
K931042
Kerma Medical Products, Inc.
General Hospital · 408d
Cleared Apr 06, 1994
SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD)
K935723
Cabot Safety Corp.
General Hospital · 133d
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 Feb 01, 1994
AGAFAR FACE SHIELD
K935779
Infection Control Products, Inc.
General Hospital · 60d
Cleared Jan 21, 1994
ISOLAIR 2 FULL FACE SPLASH GUARD
K931288
Louis M. Gerson Co., Inc.
General Hospital · 315d
Cleared Aug 18, 1993
ACTION MEDTEK FACE SHIELD
K926438
Action Eyewear Corp.
General Hospital · 238d
Cleared Jul 23, 1993
CATALOG NUMBER 111 (FACESHIELD)
K925290
Ansley Medical Products, Inc.
General Hospital · 275d
Cleared Jul 09, 1993
ULTRATUFF CUT RESISTANT GLOVE LINER
K925628
Baxter Healthcare Corp
General Hospital · 245d
Cleared Jun 15, 1993
WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS
K922407
Wells Lamont Corp.
General Hospital · 390d
Cleared May 07, 1993
MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE
K923229
Medical Armor Corp.
General Hospital · 310d
Cleared Oct 15, 1992
GUARDALL SHIELD
K915415
Anago, Inc.
General Hospital · 321d
Cleared Feb 03, 1992
FINGGUARD
K915056
Allied Signal, Inc.
General Hospital · 87d
Cleared Dec 02, 1991
REPEL(TM) LITE CUT RESISTANT GLOVE LINERS
K914077
Depuy-Raynham
General Hospital · 82d
Cleared Oct 08, 1991
MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV
K912737
Medical Armor Corp.
General Hospital · 109d
Cleared Oct 04, 1991
MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO
K912457
Medical Armor Corp.
General Hospital · 123d
Cleared Jun 27, 1991
NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER
K910890
Lovell-Schenck, Inc.
General Hospital · 128d
Cleared Jun 07, 1991
OP-D-OP VISOR SHIELDS
K911742
Op-D-Op, Inc.
General Hospital · 50d
Cleared Jan 08, 1991
PARADERM(TM) SURGEON'S GLOVE ACCESSORY
K904903
Lovell-Schenck, Inc.
General Hospital · 71d
Cleared Sep 07, 1990
SURGICAL COTTON GLOVES
K900425
Allo Pro Corp.
General Hospital · 220d
Cleared Jul 27, 1990
CUT RESISTANT GLOVE LINER
K902633
Biomet, Inc.
General Hospital · 43d