JR Engineering and Medical Technologies (M) Sdn Bhd
RASA Selangor, MY
JR ENGINEERING AND MEDICAL TECHNOLOGIES (M) SDN BHD appears in FDA device records in RASA Selangor, MY. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for JR Engineering and Medical Technologies (M) Sdn Bhd between 2019 and 2023. The busiest year on record is 2022, with 5. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 5 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222350 | Sterile Nitrile Surgical Gloves Powder Free | KGO | Substantially Equivalent | |
| K221626 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate | LZA | Substantially Equivalent | |
| K222348 | JR MEDIC | LYY | Substantially Equivalent | |
| K221169 | JR MEDIC Nitrile Examination Gloves Powder Free- Black | LZA | Substantially Equivalent | |
| K222349 | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) | LZA | Substantially Equivalent | |
| K221157 | JR Medic | LZC | Substantially Equivalent | |
| K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs | LZC | Substantially Equivalent | |
| K192328 | JR.MEDIK Latex Surgeon’s Gloves Powder Free | KGO | Substantially Equivalent | |
| K192333 | Blue Nitrile Examination Gloves Powder Free | LZA | Substantially Equivalent | |
| K192329 | Blue Latex Examination Powder Free Gloves | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016785252 | 3016785252 | JR ENGINEERING AND MEDICAL TECHNOLOGIES (M) SDN BHD | LOT 8 & 10, JALAN ZURAH 3, RASA Selangor 44200 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain