Besglove Medicare Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 22
What Besglove Medicare Sdn. Bhd. makes
The company manufactures single-use examination gloves in various materials, including powdered and powder-free nitrile, latex (with and without protein content claims), and polymer-coated variants. Products are available in blue and green colours, designed for medical and clinical examinations. Powdered latex gloves are labelled with a protein content of 50 micrograms or less, while polymer-coated options are intended to reduce powder-related risks. The portfolio includes both standard and protein-reduced latex formulations to accommodate different clinical needs.
All listed devices fall under Class I regulatory classification, requiring compliance with FDA’s 510(k) premarket notification process. The company’s products are registered with the FDA’s 510(k) database, indicating they meet applicable safety and performance standards for single-use examination gloves. The manufacturer is based in the United States.
Catalogue
Search and filter all 22 devicesFrequently asked questions
How many devices does Besglove Medicare Sdn. Bhd. have in the registry?
The registry currently lists 22 devices for Besglove Medicare Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Besglove Medicare Sdn. Bhd.'s devices?
Among its 22 most recently registered devices, Besglove Medicare Sdn. Bhd. has devices listed in FDA 510(k) (22 devices).
What risk classes do Besglove Medicare Sdn. Bhd.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for Besglove Medicare Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Besglove Medicare Sdn. Bhd. in the registry?
The most recently registered devices listed for Besglove Medicare Sdn. Bhd. include POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR), SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED), POWDERFREE GREEN NITRILE EXAMINATION GLOVES and POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS).