POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)

Surgeon's Gloves

INTERNATIONAL BIOMEDICAL, INC.

The following data is part of a premarket notification filed by International Biomedical, Inc. with the FDA for Powder-free Radiation Attenuating Neoprene Surgical Glove (black).

Pre-market Notification Details

Device IDK022873
510k NumberK022873
Device Name:POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)
ClassificationSurgeon's Gloves
Applicant INTERNATIONAL BIOMEDICAL, INC. 8508 CROSS PARK DR. Austin,  TX  78754
ContactAmy R Pieper
CorrespondentAmy R Pieper
INTERNATIONAL BIOMEDICAL, INC. 8508 CROSS PARK DR. Austin,  TX  78754
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-29
Decision Date2003-03-21
Summary:summary

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