Platinum Glove Industries Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 6
What Platinum Glove Industries Sdn. Bhd. makes
Platinum Glove Industries Sdn. Bhd. manufactures powder-free nitrile examination gloves in various colors, including white, black, blue, green, and scented variants such as grape and peppermint. Their portfolio also includes polymer-coated nitrile gloves and chemotherapy-compatible blue nitrile gloves. The company produces single-use gloves designed for medical examinations and procedures.
The company’s products are classified as Class I medical devices. Their gloves are listed under the FDA’s 510(k) pathway, indicating regulatory clearance in the United States. The manufacturer is based in Malaysia.
Catalogue
Powder Free Nitrile Examination Gloves (White) Ref K051318
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Platinum Glove Industries Sdn. Bhd. have in the registry?
The registry currently lists 6 devices for Platinum Glove Industries Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Platinum Glove Industries Sdn. Bhd.'s devices?
Among its 6 most recently registered devices, Platinum Glove Industries Sdn. Bhd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Platinum Glove Industries Sdn. Bhd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Platinum Glove Industries Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Platinum Glove Industries Sdn. Bhd. in the registry?
The most recently registered devices listed for Platinum Glove Industries Sdn. Bhd. include POWDER FREE NITRILE EXAMINATION GLOVES (WHITE), POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED, POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR and Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs.