ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Surgeon's Gloves

ANSELL PERRY

The following data is part of a premarket notification filed by Ansell Perry with the FDA for Encore Powder Free Latex Surgical Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).

Pre-market Notification Details

Device IDK001239
510k NumberK001239
Device Name:ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
ClassificationSurgeon's Gloves
Applicant ANSELL PERRY 1875 HARSH AVE. S.E. Massillon,  OH  44646 -7199
ContactJames R Chatterton
CorrespondentJames R Chatterton
ANSELL PERRY 1875 HARSH AVE. S.E. Massillon,  OH  44646 -7199
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-18
Decision Date2000-05-15

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