Koon Seng Sdn Bhd
Country not established FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Koon Seng Sdn Bhd makes
Koon Seng Sdn Bhd manufactures patient examination gloves, including nitrile and latex varieties. Their product range features powder-free and powdered options, polymer-coated latex gloves with specific protein content labeling claims, and nitrile gloves tested for use with chemotherapy drugs.
The company is based in the US, and its portfolio consists of Class I medical devices. These products are listed in the FDA 510(k) regulatory registry.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
- CE MDR 510(k) 510(k)
Patient Examination Gloves (Latex) Ref K891821
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
FDA establishments
- Koon Seng Sdn Bhd Tangkak Johor · MY FEI 3008509176
Frequently asked questions
How many devices does Koon Seng Sdn Bhd have in the registry?
The registry currently lists 6 devices for Koon Seng Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Koon Seng Sdn Bhd's devices?
Among its 6 most recently registered devices, Koon Seng Sdn Bhd has devices listed in FDA 510(k) (6 devices).
What risk classes do Koon Seng Sdn Bhd's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Koon Seng Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Koon Seng Sdn Bhd in the registry?
The most recently registered devices listed for Koon Seng Sdn Bhd include ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE, ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR, ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) and PATIENT EXAMINATION GLOVES (LATEX).
Which FDA establishments are linked to Koon Seng Sdn Bhd?
1 FDA establishment is linked to Koon Seng Sdn Bhd in the registry; they are listed on the company page.