BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE 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 Eclipse Non-pyrogenic Latex Powder-free Sterile Surgeon's Glove.

Pre-market Notification Details

Device IDK053443
510k NumberK053443
Device Name:BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE 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 Received2005-12-09
Decision Date2006-02-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060097930715 K053443 000
05060097930708 K053443 000
05060097930692 K053443 000
05060097930685 K053443 000
05060097930678 K053443 000
05060097930661 K053443 000
05060097930654 K053443 000
05060097930562 K053443 000

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