POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW)
FDA 510(k) clearance K081655 · decided 2008-07-21
Clearance details
- K-number
- K081655
- Device name
- POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW)
- Applicant
- Jiangsu Cureguard Glove Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-12
- Decision date
- 2008-07-21
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- LYZ
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Haidian District, Beijing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, recall (Z-1553-2011) | Medline Industries Inc | 2011-03-04 |
| Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Large Size, recall (Z-1554-2011) | Medline Industries Inc | 2011-03-04 |