YULEX LATEX POWDER-FREE EXAM GLOVES
FDA 510(k) clearance K063810 · decided 2008-04-18
Clearance details
- K-number
- K063810
- Device name
- YULEX LATEX POWDER-FREE EXAM GLOVES
- Applicant
- Yulex Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-12-22
- Decision date
- 2008-04-18
- Days to decision
- 483 days
- Clearance type
- Traditional
- Product code
- OIG
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Maricopa, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.