RUBBER LATEX SURGEON'S GLOVE

Surgeon's Gloves

REGENT HOSPITAL PRODUCTS

The following data is part of a premarket notification filed by Regent Hospital Products with the FDA for Rubber Latex Surgeon's Glove.

Pre-market Notification Details

Device IDK896432
510k NumberK896432
Device Name:RUBBER LATEX SURGEON'S GLOVE
ClassificationSurgeon's Gloves
Applicant REGENT HOSPITAL PRODUCTS WASHINGTON SQUARE 1050 CONNECTICUT AVENUE, N.W. Washington,  DC  20036
ContactWayne H Matelski
CorrespondentWayne H Matelski
REGENT HOSPITAL PRODUCTS WASHINGTON SQUARE 1050 CONNECTICUT AVENUE, N.W. Washington,  DC  20036
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-08
Decision Date1990-02-01

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