Kumpulan Santra (Penang) Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Kumpulan Santra (Penang) Sdn. Bhd. makes
Kumpulan Santra (Penang) Sdn. Bhd. manufactures latex examination gloves, a sterile barrier used in clinical and medical examinations to prevent cross-contamination and protect both patient and practitioner.
The company’s latex examination gloves are classified as Class I medical devices in the US and are listed under the FDA’s 510(k) premarket notification process. The manufacturer is based in the United States.
Catalogue
Latex Examination Gloves Ref K894677
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kumpulan Santra (Penang) Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Kumpulan Santra (Penang) Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kumpulan Santra (Penang) Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Kumpulan Santra (Penang) Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Kumpulan Santra (Penang) Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Kumpulan Santra (Penang) Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Kumpulan Santra (Penang) Sdn. Bhd. in the registry?
The most recently registered devices listed for Kumpulan Santra (Penang) Sdn. Bhd. include LATEX EXAMINATION GLOVES.