EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES

Polymer Patient Examination Glove

YTY INDUSTRY (MANJUNG) SDN. BHD.

The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Evergreen Non-sterile Powder-free, Colored Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK990013
510k NumberK990013
Device Name:EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant YTY INDUSTRY (MANJUNG) SDN. BHD. PO BOX 4341 Crofton,  MD  21114
ContactE J Smith
CorrespondentE J Smith
YTY INDUSTRY (MANJUNG) SDN. BHD. PO BOX 4341 Crofton,  MD  21114
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-04
Decision Date1999-03-23

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