POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS
FDA 510(k) clearance K013267 · decided 2002-03-08
Clearance details
- K-number
- K013267
- Device name
- POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS
- Applicant
- Siam Sempermed Corp., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-01
- Decision date
- 2002-03-08
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Palm Harbor, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.