Supermax Glove Manufacturing Sdn Bhd: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Supermax Glove Manufacturing Sdn Bhd” (first 2000, latest 2003), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 51 days. 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 |
|---|---|---|
| 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 | 3 | 3 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Supermax Glove Manufacturing Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024083 | GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR | LZA | 2003-01-10 | 30 |
| K014230 | STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) | KGO | 2002-03-13 | 77 |
| K013953 | AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM | LYY | 2002-02-26 | 88 |
| K013589 | CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA | LYY | 2002-01-08 | 70 |
| K010198 | STERILE POWDERED LATEX SURGEON GLOVES | KGO | 2001-02-23 | 32 |
| K000644 | SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES | LYY | 2000-03-17 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Supermax Glove Manufacturing 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Supermax Sdn Bhd (9 510(k)s)
- Supermax Plastic Products Co., Ltd. (3 510(k)s)
- Supermax Healthcare Canada Supermax Medical (1 510(k)s)
- Supermax Healthcare Canada-Supermax Medical (1 510(k)s)
- Supermax Latex Products Sdn. Bhd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Supermax Glove Manufacturing Sdn Bhd?
FDA lists 6 510(k) clearances under the applicant name “Supermax Glove Manufacturing Sdn Bhd” (first 2000, latest 2003), across 3 product codes 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 Supermax Glove Manufacturing Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Supermax Glove Manufacturing Sdn Bhd is 51 days.
Which FDA product codes appear under Supermax Glove Manufacturing Sdn Bhd?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 3); KGO (Surgeon'S Gloves, 2); LZA (Polymer Patient Examination Glove, 1).
Next steps
- See all 6 Supermax Glove Manufacturing Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Supermax Glove Manufacturing 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.