Data / Medical devices / Malaysia / Koon Seng Sdn Bhd
Koon Seng Sdn Bhd: FDA-registered device maker in Tangkak Johor, Malaysia, 6 510(k) clearances
Koon Seng Sdn Bhd is registered with the FDA (registration 3008509176) in Tangkak Johor, Malaysia. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 21, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008509176
- Address
- PTD16058, Kawasan Perindustrian Tangkak Jalan Muar, Tangkak Johor, Malaysia, 84900
- Owner or operator
- KOON SENG SDN.BHD (8040793)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 9, 2007
- Registered through
- 2026
- Brand names listed
- KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black), KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, Polymer patient examination glove Patient examination glove, specialty Medical gloves with chemotherapy labeling claims, Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citra, Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less), ROYAL IMEPRIAL Powdered Latex Examination Gloves with Protein Control Labeling Claim (200 Micrograms or Less), Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue, Royal Imperial Powder Free Polymer Coated Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2021 | K212613 | Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | Koon Seng Sdn Bhd | accessdata.fda.gov |
| February 22, 2018 | K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) | LZA | Substantially Equivalent | Koon Seng Sdn Bhd | accessdata.fda.gov |
| July 14, 2011 | K110960 | ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE | LZA | Substantially Equivalent | Koon Seng Sdn Bhd | accessdata.fda.gov |
| December 2, 2009 | K093375 | KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) | LYY | Substantially Equivalent | Koon Seng Sdn Bhd | accessdata.fda.gov |
| December 7, 2001 | K013537 | ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Koon Seng Sdn Bhd | accessdata.fda.gov |
| October 31, 2001 | K012714 | ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR | LYY | Substantially Equivalent | Koon Seng Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Latex Patient Examination Glove
Updated December 21, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.