Matang Mfg. Sdn. Bhd.: FDA clearances and approvals
Matang Mfg. Sdn. Bhd. has 8 FDA 510(k) clearances (first 1990, latest 2012), across 2 product codes in 1 review panel. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 93 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 5 | 5 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (8)
Most recent Matang Mfg. Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122131 | POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) | LZA | 2012-10-17 | 91 |
| K121368 | NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) | LZA | 2012-08-10 | 95 |
| K072614 | MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE | LYY | 2008-04-15 | 211 |
| K032549 | MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | 2003-09-08 | 21 |
| K012558 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS | LYY | 2001-09-17 | 40 |
| K000985 | MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS | LYY | 2000-04-24 | 28 |
| K982877 | MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE | LYY | 1998-11-30 | 108 |
| K896094 | LATEX EXAMINATION GLOVES | LYY | 1990-01-17 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Matang Mfg. Sdn. Bhd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Matang Mfg. Sdn. Bhd. have?
Matang Mfg. Sdn. Bhd. has 8 FDA 510(k) clearances (first 1990, latest 2012), across 2 product codes in 1 review panel.
How long does FDA take to clear Matang Mfg. Sdn. Bhd.'s 510(k)s?
The median time from FDA receipt to decision across Matang Mfg. Sdn. Bhd.'s cleared 510(k)s is 90 days.
What devices does Matang Mfg. Sdn. Bhd. make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 5); LZA (Polymer Patient Examination Glove, 3).
Has Matang Mfg. Sdn. Bhd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Matang Mfg. Sdn. Bhd. Related entities may recall under other names.
Next steps
- See all 8 Matang Mfg. Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Matang Mfg. Sdn. Bhd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.