LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)

Latex Patient Examination Glove

SIAM SEMPERMED CORP. LTD.

The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Latex Patient Examination Glove (powderfree/hypoallergenic) (modification).

Pre-market Notification Details

Device IDK954880
510k NumberK954880
Device Name:LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)
ClassificationLatex Patient Examination Glove
Applicant SIAM SEMPERMED CORP. LTD. 26 LEEWARD ISLAND Clearwater,  FL  34630
ContactDon Morris
CorrespondentDon Morris
SIAM SEMPERMED CORP. LTD. 26 LEEWARD ISLAND Clearwater,  FL  34630
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-17
Decision Date1995-11-15

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