STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
FDA 510(k) clearance K014230 · decided 2002-03-13
Clearance details
- K-number
- K014230
- Device name
- STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
- Applicant
- Supermax Glove Manufacturing Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2001-12-26
- Decision date
- 2002-03-13
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sungai Buloh, Selangor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.