B-CARE POWDERED LATEX EXAMINATION GLOVES
FDA 510(k) clearance K052845 · decided 2005-12-16
Clearance details
- K-number
- K052845
- Device name
- B-CARE POWDERED LATEX EXAMINATION GLOVES
- Applicant
- B-Care Industries Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-07
- Decision date
- 2005-12-16
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- OPE
- Advisory committee
- General Hospital
- Location
- Littleton, CO, 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 |
|---|---|---|
| LATEX EXAMINATION GLOVES (K944778) | Pt. Haloni Jane | 1994-11-17 |
| LATEX PATIENT EXAMINATION GLOVES (K895642) | Siam Sempermed Corp., Ltd. | 1989-12-05 |
Recalls involving this device
No recalls on record reference this clearance.