Aspen Glove Sdn. Bhd.
MY Last updated 22 Oct 2026
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- Devices
- 4
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
AspenMed+ Ref K213076
Sterile Latex Surgical Gloves Powder Free Ref K211478
Latex Examination Powder Free Gloves Ref K211477
Blue Nitrile Examination Glove Powder Free Ref K211479
What Aspen Glove Sdn. Bhd. makes
Aspen Glove Sdn. Bhd. manufactures a range of medical gloves, including sterile latex surgical gloves and powder-free latex examination gloves. The company also produces blue nitrile powder-free examination gloves and the AspenMed+ product line.
These devices are classified as Class I medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Frequently asked questions
What types of medical devices does Aspen Glove Sdn. Bhd. manufacture?
Aspen Glove Sdn. Bhd. specializes in the production of various medical gloves. Their product portfolio includes sterile latex surgical gloves, powder-free latex examination gloves, blue nitrile powder-free examination gloves, and the AspenMed+ product line. These offerings are designed to meet specific clinical and examination requirements.
Where is Aspen Glove Sdn. Bhd. located?
Aspen Glove Sdn. Bhd. is based in the United States. This location serves as the primary base for the company's operations and manufacturing activities as described in their registry information.
How are the medical devices from Aspen Glove Sdn. Bhd. classified and registered?
The medical devices manufactured by Aspen Glove Sdn. Bhd. are classified as Class I medical devices. Regarding their regulatory status, these specific devices are listed within the FDA 510(k) registry, which is the standard regulatory pathway for demonstrating that a device is substantially equivalent to a legally marketed predicate device.
Information
- Country
- MY