DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)— 510(k) K043508

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

2004-12-20

Decision date

2005-01-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Dothan, AL, US

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