LATEX EXAMINATION GLOVES
FDA 510(k) clearance K944778 · decided 1994-11-17
Clearance details
- K-number
- K944778
- Device name
- LATEX EXAMINATION GLOVES
- Applicant
- Pt. Haloni Jane
- Decision
- Substantially Equivalent
- Date received
- 1994-09-27
- Decision date
- 1994-11-17
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- OPE
- Advisory committee
- General Hospital
- Location
- Medan, ID
- 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 |
|---|---|---|
| B-CARE POWDERED LATEX EXAMINATION GLOVES (K052845) | B-Care Industries Co., Ltd. | 2005-12-16 |
| LATEX PATIENT EXAMINATION GLOVES (K895642) | Siam Sempermed Corp., Ltd. | 1989-12-05 |
Recalls involving this device
No recalls on record reference this clearance.