PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm
FDA 510(k) clearance K151228 · decided 2016-01-15
Clearance details
- K-number
- K151228
- Device name
- PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm
- Applicant
- Emerson & Co. Srl
- Decision
- Substantially Equivalent
- Date received
- 2015-05-07
- Decision date
- 2016-01-15
- Days to decision
- 253 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
- Genoa, IT
- 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.