TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER

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 Textured Powder-free Latex Examination Gloves With Contains 50 Micrograms Or Less Of Total Water Extractable Protein Per.

Pre-market Notification Details

Device IDK011044
510k NumberK011044
Device Name:TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
ClassificationLatex Patient Examination Glove
Applicant SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City,  CA  94587
ContactBelle L Chou
CorrespondentBelle L Chou
SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City,  CA  94587
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-05
Decision Date2001-09-10

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