SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW
FDA 510(k) clearance K062715 · decided 2006-11-03
Clearance details
- K-number
- K062715
- Device name
- SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW
- Applicant
- Baoding Guanzhong Glove Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-11
- Decision date
- 2006-11-03
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- LYZ
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rancho Mirage, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.