Tg Medical Sdn. Bhd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Tg Medical Sdn. Bhd.” (first 1994, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 69 days. 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 |
|---|---|---|
| 2012 | 1 | 299 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 112 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tg Medical Sdn. Bhd. took a median 112 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 | 3 | 3 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (9)
Most recent Tg Medical Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171276 | Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs | KGO | 2017-08-21 | 112 |
| K113393 | POWDER FREE BLACK NITRILE EXAMINATION GLOVES | LZA | 2012-09-11 | 299 |
| K993562 | POWDER FREE LATEX STERILE SURGICAL GLOVES | KGO | 1999-12-29 | 69 |
| K992841 | TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES | LZA | 1999-10-29 | 66 |
| K992360 | TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES | LZA | 1999-10-12 | 89 |
| K992219 | POWDERED LATEX STERILE SURGICAL GLOVES | KGO | 1999-07-30 | 29 |
| K990668 | POWDER FREE BLUE NITRILE GLOVE | LZA | 1999-06-03 | 93 |
| K982872 | TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 1998-10-15 | 62 |
| K941900 | POWDERED LATEX EXAM GLOVES | LYY | 1994-06-21 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Tg Medical 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 Tg Medical Sdn. Bhd.?
FDA lists 9 510(k) clearances under the applicant name “Tg Medical Sdn. Bhd.” (first 1994, latest 2017), across 3 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 Tg Medical Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tg Medical Sdn. Bhd. is 69 days.
Which FDA product codes appear under Tg Medical Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 4); KGO (Surgeon'S Gloves, 3); LYY (Latex Patient Examination Glove, 2).
Next steps
- See all 9 Tg Medical Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Tg Medical 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.