Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs— 510(k) K213289

Clearance details

Applicant

Ansell Healthcare Products, LLC

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2021-10-01

Decision date

2023-05-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Reno, NV, US

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