Biografik (Malaysia) Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 2
What Biografik (Malaysia) Sdn Bhd makes
Biografik (Malaysia) Sdn Bhd manufactures non-sterile patient examination gloves and powder-free latex examination gloves with a polymer coating. The gloves are labeled with a protein content claim of 50 micrograms or less.
These products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Bg Patient Examination Gloves, Non-Sterile Ref K961675
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biografik (Malaysia) Sdn Bhd have in the registry?
The registry currently lists 2 devices for Biografik (Malaysia) Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biografik (Malaysia) Sdn Bhd's devices?
Among its 2 most recently registered devices, Biografik (Malaysia) Sdn Bhd has devices listed in FDA 510(k) (2 devices).
What risk classes do Biografik (Malaysia) Sdn Bhd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biografik (Malaysia) Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Biografik (Malaysia) Sdn Bhd in the registry?
The most recently registered devices listed for Biografik (Malaysia) Sdn Bhd include BG PATIENT EXAMINATION GLOVES, NON-STERILE and POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS).