POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k) clearance K091663 · decided 2009-07-27
Clearance details
- K-number
- K091663
- Device name
- POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- Applicant
- Zhangjiagang Fengyuan Plastic Products Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-09
- Decision date
- 2009-07-27
- Days to decision
- 48 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
No recalls on record reference this clearance.