Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein— 510(k) K151114
Substantially EquivalentSt. Marys Rubbers Pvt, Ltd.
FDA 510(k) clearance K151114 for Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein, Substantially Equivalent on 2015-12-11. Applicant: St. Marys Rubbers Pvt, Ltd.. Device class: 1.
Clearance details
- Applicant
- St. Marys Rubbers Pvt, Ltd.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Kottayam District, Kerala, IN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.