Powercrest (M) Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 2
What Powercrest (M) Sdn. Bhd. makes
Powercrest (M) Sdn. Bhd. manufactures latex examination gloves, including both powdered and powder-free variants, designed for patient examinations and clinical use. These products are intended to provide a barrier between healthcare providers and patients to reduce the risk of infection and contamination during medical procedures.
The company’s portfolio is classified under Class I medical devices in the US and is listed in the FDA 510(k) registry. The manufacturer is based in the United States, adhering to applicable regulatory requirements for these low-risk devices.
Catalogue
Patient Examination Gloves (Latex) Ref K891637
Regimes: 510(k) Registry: 510(k)Powder-Free Latex Examination Glove Ref K934546
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Powercrest (M) Sdn. Bhd. have in the registry?
The registry currently lists 2 devices for Powercrest (M) Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Powercrest (M) Sdn. Bhd.'s devices?
Among its 2 most recently registered devices, Powercrest (M) Sdn. Bhd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Powercrest (M) Sdn. Bhd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Powercrest (M) Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Powercrest (M) Sdn. Bhd. in the registry?
The most recently registered devices listed for Powercrest (M) Sdn. Bhd. include PATIENT EXAMINATION GLOVES (LATEX) and POWDER-FREE LATEX EXAMINATION GLOVE.