Medipure Corporation (M) Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 2
What Medipure Corporation (M) Sdn. Bhd. makes
Medipure Corporation manufactures polymer-coated, powder-free latex examination gloves with protein content labeling claims, specifying ≤50 micrograms of protein per glove. Their portfolio includes natural and blue-colored variants designed for medical and clinical use.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medipure Corporation (M) Sdn. Bhd. have in the registry?
The registry currently lists 2 devices for Medipure Corporation (M) Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medipure Corporation (M) Sdn. Bhd.'s devices?
Among its 2 most recently registered devices, Medipure Corporation (M) Sdn. Bhd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Medipure Corporation (M) Sdn. Bhd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Medipure Corporation (M) Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Medipure Corporation (M) Sdn. Bhd. in the registry?
The most recently registered devices listed for Medipure Corporation (M) Sdn. Bhd. include POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) and POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS).