Pamitex Industries Sdn Bhd: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Pamitex Industries Sdn Bhd” (first 1999, latest 2001), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 69 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 | 15 | 15 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (19)
Most recent Pamitex Industries Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003350 | HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE) | LYY | 2001-04-05 | 161 |
| K001674 | POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR | LYY | 2000-06-30 | 29 |
| K000952 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR | LYY | 2000-06-30 | 98 |
| K001672 | POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES | LYY | 2000-06-23 | 22 |
| K993756 | HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES | KGO | 2000-04-28 | 175 |
| K000828 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE | LYY | 2000-04-07 | 24 |
| K993201 | HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES | KGO | 2000-03-29 | 187 |
| K993918 | HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION | LYY | 2000-02-10 | 84 |
| K993621 | HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC | LYY | 1999-12-29 | 64 |
| K993093 | HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) | LYY | 1999-10-29 | 43 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pamitex Industries 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 Pamitex Industries Sdn Bhd?
FDA lists 19 510(k) clearances under the applicant name “Pamitex Industries Sdn Bhd” (first 1999, latest 2001), 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 Pamitex Industries Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pamitex Industries Sdn Bhd is 69 days.
Which FDA product codes appear under Pamitex Industries Sdn Bhd?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 15); KGO (Surgeon'S Gloves, 2); LZA (Polymer Patient Examination Glove, 2).
Next steps
- See all 19 Pamitex Industries Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Pamitex Industries 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.