ULTRATUFF CUT RESISTANT GLOVE LINER
FDA 510(k) clearance K925628 · decided 1993-07-09
Clearance details
- K-number
- K925628
- Device name
- ULTRATUFF CUT RESISTANT GLOVE LINER
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1992-11-06
- Decision date
- 1993-07-09
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- LYU
- Device class
- 1
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Valencia, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 Scientific | 1995-12-28 |
| I-SPOUSE (K953089) | Products For Medicine | 1995-10-16 |
| SPLASH ASSIST (K952303) | Innovative Outsourcing Solutions | 1995-08-24 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |