PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL
FDA 510(k) clearance K091471 · decided 2009-10-15
Clearance details
- K-number
- K091471
- Device name
- PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL
- Applicant
- Cartagloves S.A.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-18
- Decision date
- 2009-10-15
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- LYZ
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.