Atlas FDA

LYU

56 FDA 510(k) clearances · Product code

133 daysmedian time to decision
348 days90th percentile
56clearances measured

FDA profile

Official device name
Accessory, Surgical Apparel
Device class
Class I (low risk)
Regulation
21 CFR 878.4040
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2008: 4 · 2011: 5 · 2013: 13 · 2014: 7 · 2016: 49 · 2017: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
STRYKER T4 HYTREL (R) TOGAS (K011755)Stryker Corp.2001-06-22
NURSES BOUFFANT CAP (K965237)Copioumed Intl., Inc.1997-08-27
FAR-EAST BOUFFANT CAPS (K970988)Far East Science & Technology Development Co., Ltd.1997-07-10
DISPOSABLE APRON (K964364)Instrument Makar, Inc.1997-02-25
DEPUY DISPOSABLE FILTER/HOOD (K961791)Depuy, Inc.1996-08-09
AMMI MAGNI-GUARD (K961454)American Medical Mfg., Inc.1996-07-25
SLOAN STA-DRI PANT PROTECTOR (K945302)Sloan Corp.1996-03-19
ULTRAFIT LINERS (K954314)Stahmer Weston Scientific1995-12-28
I-SPOUSE (K953089)Products For Medicine1995-10-16
SPLASH ASSIST (K952303)Innovative Outsourcing Solutions1995-08-24
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (K942200)Thantex Specialties, Inc.1995-08-07
SLOAN STA-DRI BOOTLEG LEGGING (K944276)Sloan Corp.1995-07-31
SLOAN STA-DRI SURGICAL JUMPSUIT (K944118)Sloan Corp.1995-07-31
INTEC FULL FACE SHIELD (K946003)Intec Industries, Inc.1995-06-28
INCASE EXTENSIBLE BAG--NON-STERILE (K951420)Alpha Surgical, Inc.1995-06-08
CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER (K944763)Wells Lamont Corp.1995-04-10
OP-D-OP II (K945098)Op-D-Op Visor Shields, Inc.1995-02-28
MAKAR FULL AND HALF FACE SHIELD (K942828)Instrument Makar, Inc.1995-02-23
MONOGARD FACE SHIELD (K943809)White Knight Healthcare1994-11-28
BOUFFANT CAP (K940228)Derekduck Industries Corp.1994-09-26
SHOE COVER (K940226)Derekduck Industries Corp.1994-09-26
BODY BOOT (K940723)Mark-Clark1994-09-06
SPLASH MASK (K941932)Incon Diversified Industries, Inc.1994-07-19
FACE-IT SHIELD (K942022)Onyx Medical Corp.1994-07-08
DERMAL GLOVES (K932953)George Glove Company, Inc.1994-06-24
NYLON LINER GLOVES (K940274)Wells Lamont Corp.1994-05-12
KACEY DISPOSABLE GLOVE LINER (K935158)K & C Medical, Inc.1994-04-20
MOORE SECURE CAP (K931042)Kerma Medical Products, Inc.1994-04-13
SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD) (K935723)Cabot Safety Corp.1994-04-06
TECNOL SPLASHGUARD (K934842)Tecnol Medical Products, Inc.1994-03-09
PROCEL(TM) DERMALINER GLOVE (K931094)W. L. Gore & Associates, Inc.1994-02-14
AGAFAR FACE SHIELD (K935779)Infection Control Products, Inc.1994-02-01
ISOLAIR 2 FULL FACE SPLASH GUARD (K931288)Louis M. Gerson Co., Inc.1994-01-21
ACTION MEDTEK FACE SHIELD (K926438)Action Eyewear Corp.1993-08-18
CATALOG NUMBER 111 (FACESHIELD) (K925290)Ansley Medical Products, Inc.1993-07-23
ULTRATUFF CUT RESISTANT GLOVE LINER (K925628)Baxter Healthcare Corp1993-07-09
WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS (K922407)Wells Lamont Corp.1993-06-15
MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE (K923229)Medical Armor Corp.1993-05-07
GUARDALL SHIELD (K915415)Anago, Inc.1992-10-15
FINGGUARD (K915056)Allied Signal, Inc.1992-02-03
REPEL(TM) LITE CUT RESISTANT GLOVE LINERS (K914077)Depuy-Raynham1991-12-02
MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV (K912737)Medical Armor Corp.1991-10-08
MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO (K912457)Medical Armor Corp.1991-10-04
NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER (K910890)Lovell-Schenck, Inc.1991-06-27
OP-D-OP VISOR SHIELDS (K911742)Op-D-Op, Inc.1991-06-07
PARADERM(TM) SURGEON'S GLOVE ACCESSORY (K904903)Lovell-Schenck, Inc.1991-01-08
SURGICAL COTTON GLOVES (K900425)Allo Pro Corp.1990-09-07
CUT RESISTANT GLOVE LINER (K902633)Biomet, Inc.1990-07-27
PHYSICIAN BARRIER GLOVE, SURGICAL (K901221)Dynamic Marketing Ent.1990-07-10
MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE (K902016)Aor-Sullivan1990-05-16
REPEL SURGICAL GLOVE LINERS (K900310)Depuy-Raynham1990-03-01
STERILE HAND COVER (K894064)Sage Products, Inc.1989-08-11
CYSTO APRONS IN VARIOUS SIZES (K893842)Bemiss Jason Corp.1989-08-02
AOR-SULLIVAN PROTECTIVE OVERGLOVE (K893118)Aor-Sullivan1989-06-01
PROTECT-AIDS AUTOPSY UNDERGLOVE (K880440)Medical Armor Corp.1988-10-11
PROTECT-AIDS UNDERGLOVE (K880439)Medical Armor Corp.1988-10-11

Track LYU automatically

Every clearance here is in the API, with alerts when new ones post.