Betel Care Sdn. Bhd.
MalaysiaFDA 510(k) applicant, unverified FDA
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Betel Care Sdn. Bhd. makes
Betel Care Sdn. Bhd. manufactures powder-free latex and nitrile examination gloves, including chlorinated variants with protein labeling claims of 50 micrograms or less, as well as non-sterile blue latex exam gloves.
The company's devices are classified as Class I medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Betel Powder Free Latex Exam Gloves, Chlorinated, With Protein Labeling Claim (50 Micrograms Or Less) Ref K000652
510(k) 510(k)Betel Powder Free Latex Exam Gloves Ref K000650
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
FDA establishments
- Betelcare Sdn Bhd Kapar Selangor · MY Other ID 3366
Frequently asked questions
How many devices does Betel Care Sdn. Bhd. have in the registry?
The registry currently lists 4 devices for Betel Care Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Betel Care Sdn. Bhd.'s devices?
Among its 4 most recently registered devices, Betel Care Sdn. Bhd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Betel Care Sdn. Bhd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Betel Care Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Betel Care Sdn. Bhd. in the registry?
The most recently registered devices listed for Betel Care Sdn. Bhd. include BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS), BETEL POWDER FREE LATEX EXAM GLOVES, BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE and Betel Gloves Nitrile Examination Glove Powder Free.
Which FDA establishments are linked to Betel Care Sdn. Bhd.?
1 FDA establishment is linked to Betel Care Sdn. Bhd. in the registry; they are listed on the company page.