GLOVES, FLOOR
FDA 510(k) clearance K780181 · decided 1978-02-21
Clearance details
- K-number
- K780181
- Device name
- GLOVES, FLOOR
- Applicant
- Tillotson Rubber Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-03
- Decision date
- 1978-02-21
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- FML
- Device class
- 1
- Regulation number
- 880.6140
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
|---|---|---|
| UNILET LANCET (K842517) | Ulster Scientific, Inc. | 1984-09-20 |
Recalls involving this device
No recalls on record reference this clearance.