PATIENT EXAMINATION GLOVES (LATEX)

Latex Patient Examination Glove

SHEN WEI (USA), INC.

The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Patient Examination Gloves (latex).

Pre-market Notification Details

Device IDK892742
510k NumberK892742
Device Name:PATIENT EXAMINATION GLOVES (LATEX)
ClassificationLatex Patient Examination Glove
Applicant SHEN WEI (USA), INC. 1163 CHESS DRIVE, SUITE D Foster City,  CA  94404
ContactL. U Chou
CorrespondentL. U Chou
SHEN WEI (USA), INC. 1163 CHESS DRIVE, SUITE D Foster City,  CA  94404
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-11
Decision Date1989-05-25

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