FDA Product Code
FDA Product Code LYU — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 56 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K011755 | STRYKER T4 HYTREL (R) TOGAS | Stryker Corp. | 2001-06-22 | Special | PDF ↗ |
| K965237 | NURSES BOUFFANT CAP | Copioumed Intl., Inc. | 1997-08-27 | Traditional | PDF ↗ |
| K970988 | FAR-EAST BOUFFANT CAPS | Far East Science & Technology Development Co., Ltd. | 1997-07-10 | Traditional | PDF ↗ |
| K964364 | DISPOSABLE APRON | Instrument Makar, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K961791 | DEPUY DISPOSABLE FILTER/HOOD | Depuy, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K961454 | AMMI MAGNI-GUARD | American Medical Mfg., Inc. | 1996-07-25 | Traditional | PDF ↗ |
| K945302 | SLOAN STA-DRI PANT PROTECTOR | Sloan Corp. | 1996-03-19 | Traditional | PDF ↗ |
| K954314 | ULTRAFIT LINERS | Stahmer Weston Scientific | 1995-12-28 | Traditional | PDF ↗ |
| K953089 | I-SPOUSE | Products For Medicine | 1995-10-16 | Traditional | PDF ↗ |
| K952303 | SPLASH ASSIST | Innovative Outsourcing Solutions | 1995-08-24 | Traditional | PDF ↗ |
| K942200 | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS | Thantex Specialties, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K944276 | SLOAN STA-DRI BOOTLEG LEGGING | Sloan Corp. | 1995-07-31 | Traditional | PDF ↗ |
| K944118 | SLOAN STA-DRI SURGICAL JUMPSUIT | Sloan Corp. | 1995-07-31 | Traditional | PDF ↗ |
| K946003 | INTEC FULL FACE SHIELD | Intec Industries, Inc. | 1995-06-28 | Traditional | PDF ↗ |
| K951420 | INCASE EXTENSIBLE BAG--NON-STERILE | Alpha Surgical, Inc. | 1995-06-08 | Traditional | PDF ↗ |
| K944763 | CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER | Wells Lamont Corp. | 1995-04-10 | Traditional | PDF ↗ |
| K945098 | OP-D-OP II | Op-D-Op Visor Shields, Inc. | 1995-02-28 | Traditional | PDF ↗ |
| K942828 | MAKAR FULL AND HALF FACE SHIELD | Instrument Makar, Inc. | 1995-02-23 | Traditional | PDF ↗ |
| K943809 | MONOGARD FACE SHIELD | White Knight Healthcare | 1994-11-28 | Traditional | PDF ↗ |
| K940228 | BOUFFANT CAP | Derekduck Industries Corp. | 1994-09-26 | Traditional | PDF ↗ |
| K940226 | SHOE COVER | Derekduck Industries Corp. | 1994-09-26 | Traditional | PDF ↗ |
| K940723 | BODY BOOT | Mark-Clark | 1994-09-06 | Traditional | PDF ↗ |
| K941932 | SPLASH MASK | Incon Diversified Industries, Inc. | 1994-07-19 | Traditional | PDF ↗ |
| K942022 | FACE-IT SHIELD | Onyx Medical Corp. | 1994-07-08 | Traditional | PDF ↗ |
| K932953 | DERMAL GLOVES | George Glove Company, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K940274 | NYLON LINER GLOVES | Wells Lamont Corp. | 1994-05-12 | Traditional | PDF ↗ |
| K935158 | KACEY DISPOSABLE GLOVE LINER | K & C Medical, Inc. | 1994-04-20 | Traditional | PDF ↗ |
| K931042 | MOORE SECURE CAP | Kerma Medical Products, Inc. | 1994-04-13 | Traditional | PDF ↗ |
| K935723 | SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD) | Cabot Safety Corp. | 1994-04-06 | Traditional | PDF ↗ |
| K934842 | TECNOL SPLASHGUARD | Tecnol Medical Products, Inc. | 1994-03-09 | Traditional | PDF ↗ |
| K931094 | PROCEL(TM) DERMALINER GLOVE | W. L. Gore & Associates, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K935779 | AGAFAR FACE SHIELD | Infection Control Products, Inc. | 1994-02-01 | Traditional | PDF ↗ |
| K931288 | ISOLAIR 2 FULL FACE SPLASH GUARD | Louis M. Gerson Co., Inc. | 1994-01-21 | Traditional | PDF ↗ |
| K926438 | ACTION MEDTEK FACE SHIELD | Action Eyewear Corp. | 1993-08-18 | Traditional | PDF ↗ |
| K925290 | CATALOG NUMBER 111 (FACESHIELD) | Ansley Medical Products, Inc. | 1993-07-23 | Traditional | PDF ↗ |
| K925628 | ULTRATUFF CUT RESISTANT GLOVE LINER | Baxter Healthcare Corp | 1993-07-09 | Traditional | PDF ↗ |
| K922407 | WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS | Wells Lamont Corp. | 1993-06-15 | Traditional | PDF ↗ |
| K923229 | MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE | Medical Armor Corp. | 1993-05-07 | Traditional | PDF ↗ |
| K915415 | GUARDALL SHIELD | Anago, Inc. | 1992-10-15 | Traditional | PDF ↗ |
| K915056 | FINGGUARD | Allied Signal, Inc. | 1992-02-03 | Traditional | PDF ↗ |
| K914077 | REPEL(TM) LITE CUT RESISTANT GLOVE LINERS | Depuy-Raynham | 1991-12-02 | Traditional | PDF ↗ |
| K912737 | MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV | Medical Armor Corp. | 1991-10-08 | Traditional | PDF ↗ |
| K912457 | MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO | Medical Armor Corp. | 1991-10-04 | Traditional | PDF ↗ |
| K910890 | NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER | Lovell-Schenck, Inc. | 1991-06-27 | Traditional | PDF ↗ |
| K911742 | OP-D-OP VISOR SHIELDS | Op-D-Op, Inc. | 1991-06-07 | Traditional | PDF ↗ |
| K904903 | PARADERM(TM) SURGEON'S GLOVE ACCESSORY | Lovell-Schenck, Inc. | 1991-01-08 | Traditional | PDF ↗ |
| K900425 | SURGICAL COTTON GLOVES | Allo Pro Corp. | 1990-09-07 | Traditional | PDF ↗ |
| K902633 | CUT RESISTANT GLOVE LINER | Biomet, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901221 | PHYSICIAN BARRIER GLOVE, SURGICAL | Dynamic Marketing Ent. | 1990-07-10 | Traditional | PDF ↗ |
| K902016 | MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE | Aor-Sullivan | 1990-05-16 | Traditional | PDF ↗ |
| K900310 | REPEL SURGICAL GLOVE LINERS | Depuy-Raynham | 1990-03-01 | Traditional | PDF ↗ |
| K894064 | STERILE HAND COVER | Sage Products, Inc. | 1989-08-11 | Traditional | PDF ↗ |
| K893842 | CYSTO APRONS IN VARIOUS SIZES | Bemiss Jason Corp. | 1989-08-02 | Traditional | PDF ↗ |
| K893118 | AOR-SULLIVAN PROTECTIVE OVERGLOVE | Aor-Sullivan | 1989-06-01 | Traditional | PDF ↗ |
| K880439 | PROTECT-AIDS UNDERGLOVE | Medical Armor Corp. | 1988-10-11 | Traditional | PDF ↗ |
| K880440 | PROTECT-AIDS AUTOPSY UNDERGLOVE | Medical Armor Corp. | 1988-10-11 | Traditional | PDF ↗ |
Product code LYU · Class I · General, Plastic Surgery. Data: openFDA.