Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016785252

FEI Number

3016785252

Entity Name

JR ENGINEERING &MEDICAL TECHNOLOGIES (M) SDN BHD

City/State/Country

RASA Selangor, MY

Establishment Address

LOT 8 & 10 JLN ZURAH, LOT 1& 3, JLN ZURAH 1A/1,PUSAT PERINDUSTRIAN 2, RASA Selangor 44200, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JR ENGINEERING &MEDICAL TECHNOLOGIES (M) SDN BHD (Owner Number: 10065964)

Owner / Operator Contact Address

LOT 8 & 10 JLN ZURAH, LOT 1& 3, JLN ZURAH 1A/1,PUSAT PERINDUSTRIAN 2, RASA, MY-10 44200, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222349

PMA Number

N/A

All Registered Proprietary Names

JR MEDIC JR MEDIC GUARDIAN JR MEDIC Black Nitrile Exam Powder Free Gloves Blue Latex Exam Powder Free Gloves Chemo Rated Jr Medic Blue Nitrile Examination Powder Free Gloves tested for use with chemotherapy drugs Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs Nitrile Surgical Powder Free Gloves Orange /Purple Exam Nitrile Powder Free Gloves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-03-31
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-03-31
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2020-03-31
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-11-07
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-11-07
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-01-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-01-19
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2022-01-19
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-05-02
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

JR ENGINEERING &MEDICAL TECHNOLOGIES (M) SDN BHD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21

Similar Registrations

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9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
3012551999	ST.MARYS RUBBERS PVT LTD	Kottayam Kerala, IN
3025413681	GUILIN HUADA BIOTECHNOLOGY CO., LTD.	Guilin City Guangxi, CN
8041005	WRP ASIA PACIFIC SDN. BHD.	SALAK TINGGI, SEPANG Selangor, MY
3004122598	PRODUCTOS MEDLINE S.A. DE C.V.	NUEVO LAREDO Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016785252. Last updated year: 2026. Please use registration number 3016785252 when referencing this establishment in official correspondence.