PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm— 510(k) K151228
Substantially EquivalentEmerson & Co. Srl
FDA 510(k) clearance K151228 for PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm, Substantially Equivalent on 2016-01-15. Applicant: Emerson & Co. Srl. Device class: 1.
Clearance details
- Applicant
- Emerson & Co. Srl
- 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
- Traditional
- Location
- Genoa, IT
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