Koon Seng Sdn Bhd
Tangkak Johor, MY
KOON SENG SDN BHD appears in FDA device records in Tangkak Johor, MY. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Koon Seng Sdn Bhd between 1989 and 2021. The busiest year on record is 2001, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 2001 | 2 |
| 2009 | 1 |
| 2011 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212613 | Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | |
| K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) | LZA | Substantially Equivalent | |
| K110960 | ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE | LZA | Substantially Equivalent | |
| K093375 | KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) | LYY | Substantially Equivalent | |
| K013537 | ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K012714 | ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR | LYY | Substantially Equivalent | |
| K891821 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008509176 | 3008509176 | KOON SENG SDN BHD | PTD16058, Kawasan Perindustrian Tangkak, Tangkak Johor 84900 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain