Jr Engineering & Medical Technologies (M) Sdn. Bhd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Jr Engineering & Medical Technologies (M) Sdn. Bhd.” (first 2019, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 140 days. Since 2017 the median was 140 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 90 |
| 2020 | 2 | 173 |
| 2021 | 1 | 94 |
| 2022 | 5 | 131 |
| 2023 | 1 | 253 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jr Engineering & Medical Technologies (M) Sdn. Bhd. took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 4 | 4 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| LZC | Medical Glove, Specialty | 2 | 2 |
Review panels
- General Hospital (10)
Most recent Jr Engineering & Medical Technologies (M) Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222350 | Sterile Nitrile Surgical Gloves Powder Free | KGO | 2023-04-13 | 253 |
| K221626 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate | LZA | 2022-12-07 | 184 |
| K222348 | JR MEDIC | LYY | 2022-10-27 | 85 |
| K221169 | JR MEDIC Nitrile Examination Gloves Powder Free- Black | LZA | 2022-10-25 | 186 |
| K222349 | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) | LZA | 2022-10-21 | 79 |
| K221157 | JR Medic | LZC | 2022-08-30 | 131 |
| K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs | LZC | 2021-12-06 | 94 |
| K192328 | JR.MEDIK Latex Surgeons Gloves Powder Free | KGO | 2020-03-10 | 196 |
| K192333 | Blue Nitrile Examination Gloves Powder Free | LZA | 2020-01-24 | 150 |
| K192329 | Blue Latex Examination Powder Free Gloves | LYY | 2019-11-25 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Jr Engineering & Medical Technologies (M) Sdn. Bhd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Jr Engineering & Medical Technologies (M) Sdn. Bhd.?
FDA lists 10 510(k) clearances under the applicant name “Jr Engineering & Medical Technologies (M) Sdn. Bhd.” (first 2019, latest 2023), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Jr Engineering & Medical Technologies (M) Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jr Engineering & Medical Technologies (M) Sdn. Bhd. is 140 days. Since 2017: 140 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Jr Engineering & Medical Technologies (M) Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 4); KGO (Surgeon'S Gloves, 2); LYY (Latex Patient Examination Glove, 2).
Next steps
- See all 10 Jr Engineering & Medical Technologies (M) Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Jr Engineering & Medical Technologies (M) Sdn. Bhd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.