Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs +1 more— 510(k) K142190

Clearance details

Device name as filed

Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs

Applicant

Pt. Medisafe Technologies

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2014-08-08

Decision date

2015-07-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tanjung Morawa, Medan, ID

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