Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein
FDA 510(k) clearance K151114 · decided 2015-12-11
Clearance details
- K-number
- K151114
- Device name
- Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein
- Applicant
- St. Marys Rubbers Pvt, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-27
- Decision date
- 2015-12-11
- Days to decision
- 228 days
- Clearance type
- Abbreviated
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kottayam District, Kerala, IN
- 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.