Mah Sing Healthcare Sdn. Bhd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mah Sing Healthcare Sdn. Bhd.” (first 2021, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 80 days. Since 2017 the median was 80 days, against 112 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 |
|---|---|---|
| 2021 | 1 | 115 |
| 2022 | 1 | 52 |
| 2023 | 2 | 78 |
| 2024 | 0 | — |
| 2025 | 1 | 189 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mah Sing Healthcare Sdn. Bhd. took a median 80 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Mah Sing Healthcare Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243694 | Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue | LZA | 2025-06-06 | 189 |
| K230002 | Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs | LZA | 2023-03-24 | 80 |
| K223415 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2023-01-26 | 77 |
| K214110 | Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs | LZA | 2022-02-19 | 52 |
| K212535 | Nitrile Powder Free Blue Examination Gloves, Non-Sterile | LZA | 2021-12-04 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Mah Sing Healthcare 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 Mah Sing Healthcare Sdn. Bhd.?
FDA lists 5 510(k) clearances under the applicant name “Mah Sing Healthcare Sdn. Bhd.” (first 2021, latest 2025), across 1 product code 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 Mah Sing Healthcare Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mah Sing Healthcare Sdn. Bhd. is 80 days. Since 2017: 80 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mah Sing Healthcare Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 5).
Next steps
- See all 5 Mah Sing Healthcare Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Mah Sing Healthcare 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, 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.