Great Glove Sdn Bhd
MalaysiaFDA 510(k) applicant, unverified
- Devices
- 4
What Great Glove Sdn Bhd makes
Great Glove Sdn Bhd manufactures examination gloves, including powdered latex gloves, powder-free latex gloves with specified protein levels, and powdered and powder-free nitrile blue examination gloves. These products are designed for medical and clinical use to ensure barrier protection during procedures.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed via 510(k) premarket notifications in the United States. The manufacturer is based in the US.
Catalogue
Latex Examination Powdered Gloves Ref K993386
510(k) 510(k)Great Glove Latex Examination Powderfree Gloves With Protein Labelling Claims (50 Micrograms Or Less) Ref K020363
510(k) 510(k)Nitrile Blue Powdered Examination Gloves Ref K052955
510(k) 510(k)Nitrile Blue Powder Free Examination Glove Ref K052956
510(k) 510(k)
Frequently asked questions
How many devices does Great Glove Sdn Bhd have in the registry?
The registry currently lists 4 devices for Great Glove Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Great Glove Sdn Bhd's devices?
Among its 4 most recently registered devices, Great Glove Sdn Bhd has devices listed in FDA 510(k) (4 devices).
What risk classes do Great Glove Sdn Bhd's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Great Glove Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Great Glove Sdn Bhd in the registry?
The most recently registered devices listed for Great Glove Sdn Bhd include LATEX EXAMINATION POWDERED GLOVES, GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS), NITRILE BLUE POWDERED EXAMINATION GLOVES and NITRILE BLUE POWDER FREE EXAMINATION GLOVE.