BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE

Surgeon's Gloves

REGENT MEDICAL AMERICAS, LLC

The following data is part of a premarket notification filed by Regent Medical Americas, Llc with the FDA for Biogel Skinsense Powder-free Non-latex Surgeon's Glove.

Pre-market Notification Details

Device IDK053102
510k NumberK053102
Device Name:BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
ClassificationSurgeon's Gloves
Applicant REGENT MEDICAL AMERICAS, LLC 3585 ENGINEERING DR, STE 250 Norcross,  GA  30092
ContactKathleen Harris
CorrespondentKathleen Harris
REGENT MEDICAL AMERICAS, LLC 3585 ENGINEERING DR, STE 250 Norcross,  GA  30092
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-04
Decision Date2006-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055186403614 K053102 000
05055186403683 K053102 000
05055186403676 K053102 000
05055186403669 K053102 000
05055186403652 K053102 000
05055186403645 K053102 000
05055186403553 K053102 000
05055186403621 K053102 000

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