Blue Latex Examination Powder Free Gloves

Latex 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 Latex Examination Powder Free Gloves.

Pre-market Notification Details

Device IDK192329
510k NumberK192329
Device Name:Blue Latex Examination Powder Free Gloves
ClassificationLatex 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 Surbramaniam
CorrespondentManoj Zacharias
Liberty Management Group Ltd. 75 Executive Dr, STE 114 Aurora,  IL  60504
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-27
Decision Date2019-11-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30796326000923 K192329 000
30796326000954 K192329 000
30796326000947 K192329 000
30796326000930 K192329 000

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