STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)

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 Sterile Powder-free Latex Examination Gloves With Polymer Coating And Protein Claim (50 Ug Or Less).

Pre-market Notification Details

Device IDK051329
510k NumberK051329
Device Name:STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)
ClassificationLatex Patient Examination Glove
Applicant SIAM SEMPERMED CORP. LTD. 13900 49TH STREET NORTH Clearwater,  FL  33762
ContactWilliam E Harris
CorrespondentWilliam E Harris
SIAM SEMPERMED CORP. LTD. 13900 49TH STREET NORTH Clearwater,  FL  33762
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-20
Decision Date2005-07-19
Summary:summary

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