POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
FDA 510(k) clearance K120968 · decided 2012-09-19
Clearance details
- K-number
- K120968
- Device name
- POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
- Applicant
- Tangshan Zhonghong Pulin Plastic Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2012-03-30
- Decision date
- 2012-09-19
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- LYZ
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Beijing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14- recall (Z-0741-2017) | CYPRESS MEDICAL PRODUCTS | 2016-12-12 |