Maxter Glove Manufacturing Sdn Bhd: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Maxter Glove Manufacturing Sdn Bhd” (first 2001, latest 2018), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 84 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 | 1 | 110 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 342 |
| 2017 | 0 | — |
| 2018 | 1 | 224 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Maxter Glove Manufacturing Sdn Bhd took a median 224 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
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 | 2 | 2 |
| LZC | Medical Glove, Specialty | 2 | 2 |
Review panels
- General Hospital (9)
Most recent Maxter Glove Manufacturing Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172864 | Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | 2018-05-02 | 224 |
| K151390 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs | LZC | 2016-05-02 | 342 |
| K113100 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | 2012-02-06 | 110 |
| K040176 | MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES | LZA | 2004-02-24 | 29 |
| K032501 | MAXTER STERILE POWDER FREE SURGICAL GLOVES | KGO | 2003-10-17 | 65 |
| K032467 | MAXTER STERILE POWDERED LATEX SURGICAL GLOVES | KGO | 2003-10-10 | 60 |
| K013554 | POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2002-01-17 | 84 |
| K013498 | CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2002-01-17 | 87 |
| K013443 | POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 | LYY | 2001-11-29 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Maxter 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.
- Maxter Catheters (1 510(k)s)
- Maxter Healthcare, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Maxter Glove Manufacturing Sdn Bhd?
FDA lists 9 510(k) clearances under the applicant name “Maxter Glove Manufacturing Sdn Bhd” (first 2001, latest 2018), across 4 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 Maxter Glove Manufacturing Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Maxter Glove Manufacturing Sdn Bhd is 84 days.
Which FDA product codes appear under Maxter 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, 2).
Next steps
- See all 9 Maxter Glove Manufacturing Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Maxter 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.