POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
FDA 510(k) clearance K111459 · decided 2011-06-16
Clearance details
- K-number
- K111459
- Device name
- POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
- Applicant
- Jiangsu Alfa Glove Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-26
- Decision date
- 2011-06-16
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- LYZ
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Haidian Dis, Beijing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.