Sri Trang Gloves (Thailand) Public Company Limited: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Sri Trang Gloves (Thailand) Public Company Limited” (first 2020, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 222 days. Since 2017 the median was 222 days, against 114 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 |
|---|---|---|
| 2020 | 2 | 62 |
| 2021 | 0 | — |
| 2022 | 3 | 259 |
| 2023 | 0 | — |
| 2024 | 2 | 240 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sri Trang Gloves (Thailand) Public Company Limited took a median 222 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 4 | 4 |
| LYY | Latex Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (7)
Most recent Sri Trang Gloves (Thailand) Public Company Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | LYY | 2024-09-09 | 222 |
| K232614 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) | LZA | 2024-05-13 | 259 |
| K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | LZA | 2022-11-20 | 212 |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | LYY | 2022-08-09 | 365 |
| K212309 | Non-sterile, Powder-Free Latex Examination Glove | LYY | 2022-04-08 | 259 |
| K200539 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl | LZA | 2020-04-09 | 37 |
| K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster | LZA | 2020-03-20 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Sri Trang Gloves (Thailand) Public Company Limited.
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 Sri Trang Gloves (Thailand) Public Company Limited?
FDA lists 7 510(k) clearances under the applicant name “Sri Trang Gloves (Thailand) Public Company Limited” (first 2020, latest 2024), across 2 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 Sri Trang Gloves (Thailand) Public Company Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sri Trang Gloves (Thailand) Public Company Limited is 222 days. Since 2017: 222 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sri Trang Gloves (Thailand) Public Company Limited?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 4); LYY (Latex Patient Examination Glove, 3).
Next steps
- See all 7 Sri Trang Gloves (Thailand) Public Company Limited clearances with predicates and recalls
- Run predicate analysis for product code LZA, Sri Trang Gloves (Thailand) Public Company Limited'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.