Kl-Kepong Rubber Products Sdn. Bhd.
MalaysiaFDA applicant, unverified FDA FEI 3018167658
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Kl-Kepong Rubber Products Sdn. Bhd. makes
Kl-Kepong Rubber Products Sdn. Bhd. manufactures powder-free nitrile examination gloves, including variants designed for use with chemotherapy drugs, fentanyl citrate, and gastric acid. Their portfolio also includes polymer-coated acrylic-based patient examination gloves, specifically formulated to reduce dermatitis risk.
These products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The manufacturer operates from the United States, adhering to regulatory standards applicable to low-risk examination gloves.
Catalogue
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves Ref K220118
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3018167658
- Address
- Lot 134905, 3/4 Mile Off Jalan Bercham, IPOH Perak
Frequently asked questions
How many devices does Kl-Kepong Rubber Products Sdn. Bhd. have in the registry?
The registry currently lists 3 devices for Kl-Kepong Rubber Products Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kl-Kepong Rubber Products Sdn. Bhd.'s devices?
Among its 3 most recently registered devices, Kl-Kepong Rubber Products Sdn. Bhd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Kl-Kepong Rubber Products Sdn. Bhd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Kl-Kepong Rubber Products Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Kl-Kepong Rubber Products Sdn. Bhd. in the registry?
The most recently registered devices listed for Kl-Kepong Rubber Products Sdn. Bhd. include Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves, POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES and Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid.