Pascorp Newmarket Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Pascorp Newmarket Sdn. Bhd. makes
Pascorp Newmarket Sdn. Bhd. manufactures patient examination gloves, designed for single-use medical procedures requiring sterile barriers.
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 US.
Catalogue
Patient Examination Gloves Ref K894449
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pascorp Newmarket Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Pascorp Newmarket Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pascorp Newmarket Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Pascorp Newmarket Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Pascorp Newmarket Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Pascorp Newmarket Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pascorp Newmarket Sdn. Bhd. in the registry?
The most recently registered devices listed for Pascorp Newmarket Sdn. Bhd. include PATIENT EXAMINATION GLOVES.