DERMA PRENE

Surgeon's Gloves

ANSELL, INC.

The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Derma Prene.

Pre-market Notification Details

Device IDK820665
510k NumberK820665
Device Name:DERMA PRENE
ClassificationSurgeon's Gloves
Applicant ANSELL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-03-11
Decision Date1982-05-03

Trademark Results [DERMA PRENE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DERMA PRENE
DERMA PRENE
73397001 1275979 Live/Registered
Ansell Incorporated
1982-09-30

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