GLOVES, APARTICULATE SURGICAL

Surgeon's Gloves

DEKNATEL, INC.

The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Gloves, Aparticulate Surgical.

Pre-market Notification Details

Device IDK760248
510k NumberK760248
Device Name:GLOVES, APARTICULATE SURGICAL
ClassificationSurgeon's Gloves
Applicant DEKNATEL, INC. 600 AIRPORT RD. Fall River,  MA  02720
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-07-19
Decision Date1976-08-09

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