Koon Seng Sdn Bhd: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Koon Seng Sdn Bhd” (first 1989, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 | 1 | 307 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 125 |
| 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 Koon Seng Sdn Bhd took a median 216 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 4 | 4 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (7)
Most recent Koon Seng Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212613 | Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) | LZA | 2021-12-21 | 125 |
| K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) | LZA | 2018-02-22 | 307 |
| K110960 | ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE | LZA | 2011-07-14 | 100 |
| K093375 | KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) | LYY | 2009-12-02 | 34 |
| K013537 | ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | LYY | 2001-12-07 | 45 |
| K012714 | ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR | LYY | 2001-10-31 | 78 |
| K891821 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-05-31 | 68 |
Recalls
openFDA lists no recalls under a recalling firm named Koon Seng 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 Koon Seng Sdn Bhd?
FDA lists 7 510(k) clearances under the applicant name “Koon Seng Sdn Bhd” (first 1989, latest 2021), 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 Koon Seng Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Koon Seng Sdn Bhd is 78 days.
Which FDA product codes appear under Koon Seng Sdn Bhd?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); LZA (Polymer Patient Examination Glove, 3).
Next steps
- See all 7 Koon Seng Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Koon Seng 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.