LYU · Class I · 21 CFR 878.4040

FDA Product Code LYU: Accessory, Surgical Apparel

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

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 Dec 28, 1995
ULTRAFIT LINERS
K954314
Stahmer Weston Scientific
General Hospital · 104d
Cleared Oct 16, 1995
I-SPOUSE
K953089
Products For Medicine
General Hospital · 105d
Cleared Aug 24, 1995
SPLASH ASSIST
K952303
Innovative Outsourcing Solutions
General Hospital · 100d
Cleared Aug 07, 1995
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
K942200
Thantex Specialties, Inc.
General Hospital · 459d
Cleared Jul 31, 1995
SLOAN STA-DRI SURGICAL JUMPSUIT
K944118
Sloan Corp.
General Hospital · 342d
Cleared Jul 31, 1995
SLOAN STA-DRI BOOTLEG LEGGING
K944276
Sloan Corp.
General Hospital · 335d
Cleared Jun 28, 1995
INTEC FULL FACE SHIELD
K946003
Intec Industries, Inc.
General Hospital · 201d
Cleared Jun 08, 1995
INCASE EXTENSIBLE BAG--NON-STERILE
K951420
Alpha Surgical, Inc.
General Hospital · 73d
Cleared Apr 10, 1995
CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER
K944763
Wells Lamont Corp.
General Hospital · 195d
Cleared Feb 28, 1995
OP-D-OP II
K945098
Op-D-Op Visor Shields, Inc.
General Hospital · 133d
Cleared Feb 23, 1995
MAKAR FULL AND HALF FACE SHIELD
K942828
Instrument Makar, Inc.
General Hospital · 254d
Cleared Nov 28, 1994
MONOGARD FACE SHIELD
K943809
White Knight Healthcare
General Hospital · 116d
Cleared Sep 26, 1994
SHOE COVER
K940226
Derekduck Industries Corp.
General Hospital · 255d
Cleared Sep 26, 1994
BOUFFANT CAP
K940228
Derekduck Industries Corp.
General Hospital · 255d
Cleared Sep 06, 1994
BODY BOOT
K940723
Mark-Clark
General Hospital · 200d
Cleared Jul 19, 1994
SPLASH MASK
K941932
Incon Diversified Industries, Inc.
General Hospital · 90d
Cleared Jul 08, 1994
FACE-IT SHIELD
K942022
Onyx Medical Corp.
General Hospital · 73d

About Product Code LYU - Regulatory Context