STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)
FDA 510(k) clearance K051329 · decided 2005-07-19
Clearance details
- K-number
- K051329
- Device name
- STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)
- Applicant
- Siam Sempermed Corp., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-20
- Decision date
- 2005-07-19
- Days to decision
- 60 days
- Clearance type
- Abbreviated
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.