Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy— 510(k) K173258

Clearance details

Applicant

Pt. Medisafe Technologies

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2017-10-10

Decision date

2018-04-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Medan, ID

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