POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)

Latex Patient Examination Glove

SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.

The following data is part of a premarket notification filed by Shun Thai Rubber Gloves Industry Public Co., Ltd. with the FDA for Polymer Coated, Chlorinated, Powder-free Latex Examination Gloves With Protein Labeling (less Than 50 Ug/g Per Glove).

Pre-market Notification Details

Device IDK040406
510k NumberK040406
Device Name:POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
ClassificationLatex Patient Examination Glove
Applicant SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434
ContactJanna P Tucker
CorrespondentJanna P Tucker
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-17
Decision Date2004-05-14

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