Supermax Sdn Bhd: FDA clearances and approvals
Supermax Sdn Bhd has 9 FDA 510(k) clearances (first 1990, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time: 112 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 | 6 | 6 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (9)
Most recent Supermax Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013774 | CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA | LZA | 2002-03-05 | 112 |
| K993865 | GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES | LYY | 2000-01-20 | 66 |
| K993864 | COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES | LYY | 2000-01-20 | 66 |
| K993258 | SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES | LZA | 1999-10-27 | 28 |
| K991415 | SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES | LYY | 1999-05-26 | 33 |
| K980966 | SUPERGLOVES POWDERED NITRILE | LZA | 1998-07-22 | 128 |
| K980494 | SUPERGLOVES | LYY | 1998-06-09 | 120 |
| K915251 | PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC | LYY | 1993-01-22 | 436 |
| K892287 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1990-01-10 | 279 |
Recalls
openFDA lists no recalls under a recalling firm named Supermax 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 Supermax Sdn Bhd have?
Supermax Sdn Bhd has 9 FDA 510(k) clearances (first 1990, latest 2002), across 2 product codes in 1 review panel.
How long does FDA take to clear Supermax Sdn Bhd's 510(k)s?
The median time from FDA receipt to decision across Supermax Sdn Bhd's cleared 510(k)s is 112 days.
What devices does Supermax Sdn Bhd make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 6); LZA (Polymer Patient Examination Glove, 3).
Has Supermax Sdn Bhd had device recalls?
openFDA lists no recalls under a recalling firm name matching Supermax Sdn Bhd. Related entities may recall under other names.
Next steps
- See all 9 Supermax Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Supermax 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.