Hl Rubber Industries Sdn Bhd: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Hl Rubber Industries Sdn Bhd” (first 2007, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 | 1 | 45 |
| 2014 | 2 | 139 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 90 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hl Rubber Industries Sdn Bhd took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 6 | 6 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Hl Rubber Industries Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs | LZC | 2022-05-26 | 90 |
| K141021 | POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR | LZA | 2014-08-26 | 127 |
| K140316 | EXAMINATION GLOVES | LZA | 2014-07-11 | 151 |
| K130038 | POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | 2013-02-21 | 45 |
| K100369 | POWDER-FREE NITRILE GLOVES, BLACK | LZA | 2010-05-20 | 97 |
| K063522 | POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) | LZA | 2007-02-08 | 78 |
| K063524 | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) | LZA | 2007-01-23 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Hl Rubber 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 Hl Rubber Industries Sdn Bhd?
FDA lists 7 510(k) clearances under the applicant name “Hl Rubber Industries Sdn Bhd” (first 2007, latest 2022), across 2 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 Hl Rubber Industries Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hl Rubber Industries Sdn Bhd is 90 days.
Which FDA product codes appear under Hl Rubber Industries Sdn Bhd?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 6); LZC (Medical Glove, Specialty, 1).
Next steps
- See all 7 Hl Rubber Industries Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LZA, Hl Rubber 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.