Blue Nitrile Examination Gloves Powder Free

Polymer Patient Examination Glove

JR Engineering & Medical Technologies (M) SDN.BHD.

The following data is part of a premarket notification filed by Jr Engineering & Medical Technologies (m) Sdn.bhd. with the FDA for Blue Nitrile Examination Gloves Powder Free.

Pre-market Notification Details

Device IDK192333
510k NumberK192333
Device Name:Blue Nitrile Examination Gloves Powder Free
ClassificationPolymer Patient Examination Glove
Applicant JR Engineering & Medical Technologies (M) SDN.BHD. Lot 8 &10, Jalan Zurah 3 & Lot 1 & 3, Jalan Zurah 3A/1, Pusat Perindustrian 2 Hulu Selangor,  MY 44200
ContactGanesan Sburamaniam
CorrespondentManoj Zacharias
Liberty Management Group Ltd. 75 Executive Dr, STE 114 Aurora,  IL  60504
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-27
Decision Date2020-01-24
Summary:summary

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.