LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

REGENT GROUP CO., LTD.

The following data is part of a premarket notification filed by Regent Group Co., Ltd. with the FDA for Latex Examination Gloves.

Pre-market Notification Details

Device IDK893263
510k NumberK893263
Device Name:LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant REGENT GROUP CO., LTD. 10F, 80, SUNG-CHIANG ROAD Taipei,  TW 10428
ContactTai Chou
CorrespondentTai Chou
REGENT GROUP CO., LTD. 10F, 80, SUNG-CHIANG ROAD Taipei,  TW 10428
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-17
Decision Date1989-09-08

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