Gx Corporation Sdn Bhd: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Gx Corporation Sdn Bhd” (first 2007, latest 2021), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 94 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 199 |
| 2020 | 0 | — |
| 2021 | 1 | 459 |
| 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 Gx Corporation Sdn Bhd took a median 329 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 | 15 | 15 |
| KGO | Surgeon'S Gloves | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (18)
Most recent Gx Corporation Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200915 | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs | KGO | 2021-07-09 | 459 |
| K183354 | Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate | LZA | 2019-06-20 | 199 |
| K111328 | POWDER FREE NITRILE EXAMINATION GLOVES | LZA | 2011-07-15 | 65 |
| K102074 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) | LZA | 2010-11-02 | 99 |
| K101828 | POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LYY | 2010-10-04 | 95 |
| K091851 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | 2009-12-28 | 189 |
| K092072 | POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE | LZA | 2009-11-04 | 119 |
| K091643 | POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZC | 2009-11-02 | 151 |
| K092200 | POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) | LZA | 2009-09-16 | 56 |
| K091151 | POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN | LZA | 2009-06-01 | 42 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gx Corporation 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 Gx Corporation Sdn Bhd?
FDA lists 18 510(k) clearances under the applicant name “Gx Corporation Sdn Bhd” (first 2007, latest 2021), 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 Gx Corporation Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gx Corporation Sdn Bhd is 94 days.
Which FDA product codes appear under Gx Corporation Sdn Bhd?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 15); KGO (Surgeon'S Gloves, 1); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 18 Gx Corporation Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LZA, Gx Corporation 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.