VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
FDA 510(k) clearance K093264 · decided 2010-05-28
Clearance details
- K-number
- K093264
- Device name
- VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
- Applicant
- Qingdao Lang Hui Import & Export Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-19
- Decision date
- 2010-05-28
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- LYZ
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Qingdao, Shandong, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves p recall (Z-0679-2012) | Cypress Medical Products LLC | 2012-01-11 |
| Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves pe recall (Z-0680-2012) | Cypress Medical Products LLC | 2012-01-11 |
| Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves recall (Z-0681-2012) | Cypress Medical Products LLC | 2012-01-11 |