TRIFLEX SURGEON'S GLOVES

Surgeon's Gloves

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Triflex Surgeon's Gloves.

Pre-market Notification Details

Device IDK832448
510k NumberK832448
Device Name:TRIFLEX SURGEON'S GLOVES
ClassificationSurgeon's Gloves
Applicant TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-25
Decision Date1984-01-27

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