Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mah Sing Healthcare Sdn. Bhd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243694 | Nitrile Powder Free Examination Glove with Tremella Fuciform | Mah Sing Healthcare Sdn. Bhd. | 2025-06-06 | 189 | 0 |
| K230002 | Nitrile Powder Free Black Patient Examination Gloves, Non-st | Mah Sing Healthcare Sdn. Bhd. | 2023-03-24 | 80 | 0 |
| K223415 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Ste | Mah Sing Healthcare Sdn. Bhd. | 2023-01-26 | 77 | 0 |
| K214110 | Nitrile Powder Free Blue Patient Examination Gloves Non-Ster | Mah Sing Healthcare Sdn. Bhd. | 2022-02-19 | 52 | 0 |
| K212535 | Nitrile Powder Free Blue Examination Gloves, Non-Sterile | Mah Sing Healthcare Sdn. Bhd. | 2021-12-04 | 115 | 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