Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Sri Trang Gloves (Thailand) Public Company Limited · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
222 daysmedian FDA review time
365 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural | Sri Trang Gloves (Thailand) Public Company Limited | 2024-09-09 | 222 | 0 |
| K240930 | Non-sterile, Powder-Free Nitrile Examination Glove Tested fo | Sri Trang Gloves Thailand (Public Company Limited) | 2024-07-02 | 89 | 0 |
| K232614 | Non-sterile, Powder-Free Nitrile Examination Glove Tested fo | Sri Trang Gloves (Thailand) Public Company Limited | 2024-05-13 | 259 | 0 |
| K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Bl | Sri Trang Gloves (Thailand) Public Company Limited | 2022-11-20 | 212 | 0 |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, | Sri Trang Gloves (Thailand) Public Company Limited | 2022-08-09 | 365 | 0 |
| K212309 | Non-sterile, Powder-Free Latex Examination Glove | Sri Trang Gloves (Thailand) Public Company Limited | 2022-04-08 | 259 | 0 |
| K200539 | Non-sterile, Powder-Free Nitrile Examination Glove Tested fo | Sri Trang Gloves (Thailand) Public Company Limited | 2020-04-09 | 37 | 0 |
| K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use w | Sri Trang Gloves (Thailand) Public Company Limited | 2020-03-20 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda