MAXXUS ORTHOPAEDIC SURGICAL GLOVES

Surgeon's Gloves

JOHNSON & JOHNSON MEDICAL, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Maxxus Orthopaedic Surgical Gloves.

Pre-market Notification Details

Device IDK953641
510k NumberK953641
Device Name:MAXXUS ORTHOPAEDIC SURGICAL GLOVES
ClassificationSurgeon's Gloves
Applicant JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington,  TX  76004 -0130
ContactMargaret L Marsh
CorrespondentMargaret L Marsh
JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington,  TX  76004 -0130
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-04
Decision Date1995-09-15

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