Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)— 510(k) K211621

Clearance details

Applicant

Careplus (M) Sdn Bhd

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2021-05-26

Decision date

2021-10-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Seremban, MY

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