COLOURED POWDWR-FREE SURGICAL GLOVES— 510(k) K980412

Substantially Equivalent

Kenwell International , Ltd.

FDA 510(k) clearance K980412 for COLOURED POWDWR-FREE SURGICAL GLOVES, Substantially Equivalent on 1998-04-08. Applicant: Kenwell International , Ltd.. Device class: 1.

Clearance details

Applicant
Kenwell International , 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
Traditional
Location
Great Neck,, NY, US
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