Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mercator Medical (Thailand), Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
200 daysmedian FDA review time
330 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, | Mercator Medical (Thailand), Ltd. | 2025-11-17 | 217 | 0 |
| K213548 | Nitrylex Classic Powder Free Nitrile Blue Examination Gloves | Mercator Medical (Thailand), Ltd. | 2022-02-21 | 105 | 0 |
| K200967 | mCare(R) Powder Free Nitrile Orange Examination Gloves | Mercator Medical (Thailand), Ltd. | 2020-06-06 | 57 | 0 |
| K192444 | mCare® Powder Free Nitrile Black Examination Glove | Mercator Medical (Thailand), Ltd. | 2019-12-31 | 116 | 0 |
| K190876 | mCare®Powder-free Nitrile Blue Examination Gloves with Chemo | Mercator Medical (Thailand), Ltd. | 2019-12-02 | 242 | 0 |
| K172930 | mCare Powder-free Blue Nitrile Examination Gloves | Mercator Medical (Thailand), Ltd. | 2018-04-13 | 200 | 0 |
| K141042 | MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES | Mercator Medical (Thailand), Ltd. | 2015-03-19 | 330 | 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