LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
FDA 510(k) clearance K980827 · decided 1998-05-04
Clearance details
- K-number
- K980827
- Device name
- LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
- Applicant
- Tucker & Associates
- Decision
- Substantially Equivalent
- Date received
- 1998-03-03
- Decision date
- 1998-05-04
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- LZB
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sparks, NV, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX (K052387) | Arthrex, Inc. | 2005-11-29 |
| PERCUGUARD (K992539) | Digit-Pro | 2000-02-18 |
| BETHEL PLUS MULTIPLE NAMES (K912042) | Bethel Latex Products, Inc. | 1991-07-02 |
| LATEX FINGER COTS (K903073) | Dongkuk Trading Co., Ltd. | 1990-09-12 |
Recalls involving this device
No recalls on record reference this clearance.