JR.MEDIK Latex Surgeon’s Gloves Powder Free

Surgeon's Gloves

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 Jr.medik Latex Surgeon’s Gloves Powder Free.

Pre-market Notification Details

Device IDK192328
510k NumberK192328
Device Name:JR.MEDIK Latex Surgeon’s Gloves Powder Free
ClassificationSurgeon's Gloves
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 Subramaniam
CorrespondentManoj Zacharias
Liberty Management Group Ltd. 75 Executive Dr, STE 114 Aurora,  IL  60504
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral Hospital
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-27
Decision Date2020-03-10

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