Data / Medical devices / Malaysia / JR Engineering And Medical Technologies (M) Sdn Bhd
JR Engineering And Medical Technologies (M) Sdn Bhd: FDA-registered device maker in RASA Selangor, Malaysia, 10 510(k) clearances
JR Engineering And Medical Technologies (M) Sdn Bhd is registered with the FDA (registration 3016785252) in RASA Selangor, Malaysia. It lists 6 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016785252
- Address
- Lot 8 & 10, Jalan Zurah 3 Lot 1& 3, Pusat Perindustrian 2, RASA Selangor, Malaysia, 44200
- Owner or operator
- JR ENGINEERING AND MEDICAL TECHNOLOGIES(M) SDN BHD (10065964)
- Roles
- Manufacturer
- First device listed
- March 31, 2020
- Registered through
- 2026
- Brand names listed
- Black Nitrile Exam Powder Free Gloves, Blue Latex Exam Powder Free Gloves Chemo Rated, Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs, GUARDIAN, JR MEDIC, Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate, Jr Medic Blue Nitrile Examination Powder Free Gloves tested for use with chemotherapy drugs, Latex Examination Powder-free Gloves and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 13, 2023 | K222350 | Sterile Nitrile Surgical Gloves Powder Free | KGO | Substantially Equivalent | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | accessdata.fda.gov |
| December 7, 2022 | K221626 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | accessdata.fda.gov |
| October 27, 2022 | K222348 | JR MEDIC | LYY | Substantially Equivalent | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | accessdata.fda.gov |
| October 25, 2022 | K221169 | JR MEDIC Nitrile Examination Gloves Powder Free- Black | LZA | Substantially Equivalent | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | accessdata.fda.gov |
| October 21, 2022 | K222349 | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) | LZA | Substantially Equivalent | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | accessdata.fda.gov |
| August 30, 2022 | K221157 | JR Medic | LZC | Substantially Equivalent | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | accessdata.fda.gov |
| December 6, 2021 | K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs | LZC | Substantially Equivalent | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | accessdata.fda.gov |
| March 10, 2020 | K192328 | JR.MEDIK Latex Surgeons Gloves Powder Free | KGO | Substantially Equivalent | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | accessdata.fda.gov |
| January 24, 2020 | K192333 | Blue Nitrile Examination Gloves Powder Free | LZA | Substantially Equivalent | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | accessdata.fda.gov |
| November 25, 2019 | K192329 | Blue Latex Examination Powder Free Gloves | LYY | Substantially Equivalent | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Surgeon'S Gloves
- All makers of Latex Patient Examination Glove
Updated April 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.