Product code LYU
- Device name
- Accessory, Surgical Apparel
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4040
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011755 | STRYKER T4 HYTREL (R) TOGAS | Stryker Corp. | 2001-06-22 |
| K965237 | NURSES BOUFFANT CAP | Copioumed Intl., Inc. | 1997-08-27 |
| K970988 | FAR-EAST BOUFFANT CAPS | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| K964364 | DISPOSABLE APRON | Instrument Makar, Inc. | 1997-02-25 |
| K961791 | DEPUY DISPOSABLE FILTER/HOOD | Depuy, Inc. | 1996-08-09 |
| K961454 | AMMI MAGNI-GUARD | American Medical Mfg., Inc. | 1996-07-25 |
| K945302 | SLOAN STA-DRI PANT PROTECTOR | Sloan Corp. | 1996-03-19 |
| K954314 | ULTRAFIT LINERS | Stahmer Weston Scientific | 1995-12-28 |
| K953089 | I-SPOUSE | Products For Medicine | 1995-10-16 |
| K952303 | SPLASH ASSIST | Innovative Outsourcing Solutions | 1995-08-24 |
| K942200 | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS | Thantex Specialties, Inc. | 1995-08-07 |
| K944118 | SLOAN STA-DRI SURGICAL JUMPSUIT | Sloan Corp. | 1995-07-31 |
| K944276 | SLOAN STA-DRI BOOTLEG LEGGING | Sloan Corp. | 1995-07-31 |
| K946003 | INTEC FULL FACE SHIELD | Intec Industries, Inc. | 1995-06-28 |
| K951420 | INCASE EXTENSIBLE BAG--NON-STERILE | Alpha Surgical, Inc. | 1995-06-08 |
| K944763 | CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER | Wells Lamont Corp. | 1995-04-10 |
| K945098 | OP-D-OP II | Op-D-Op Visor Shields, Inc. | 1995-02-28 |
| K942828 | MAKAR FULL AND HALF FACE SHIELD | Instrument Makar, Inc. | 1995-02-23 |
| K943809 | MONOGARD FACE SHIELD | White Knight Healthcare | 1994-11-28 |
| K940226 | SHOE COVER | Derekduck Industries Corp. | 1994-09-26 |
| K940228 | BOUFFANT CAP | Derekduck Industries Corp. | 1994-09-26 |
| K940723 | BODY BOOT | Mark-Clark | 1994-09-06 |
| K941932 | SPLASH MASK | Incon Diversified Industries, Inc. | 1994-07-19 |
| K942022 | FACE-IT SHIELD | Onyx Medical Corp. | 1994-07-08 |
| K932953 | DERMAL GLOVES | George Glove Company, Inc. | 1994-06-24 |
| K940274 | NYLON LINER GLOVES | Wells Lamont Corp. | 1994-05-12 |
| K935158 | KACEY DISPOSABLE GLOVE LINER | K & C Medical, Inc. | 1994-04-20 |
| K931042 | MOORE SECURE CAP | Kerma Medical Products, Inc. | 1994-04-13 |
| K935723 | SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD) | Cabot Safety Corp. | 1994-04-06 |
| K934842 | TECNOL SPLASHGUARD | Tecnol Medical Products, Inc. | 1994-03-09 |
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