Ar Alliance Healthcare Sdn. Bhd.
MalaysiaFDA 510(k) applicant, unverified
- Devices
- 4
Catalogue
Ultra Touch Powdered Latex Examination Gloves Ref K020359
Nitri Grip Powdered Nitrile Examination Gloves Ref K022572
Powder Free Nitrile Examination Gloves Ref K022619
What Ar Alliance Healthcare Sdn. Bhd. makes
The company manufactures single-use examination gloves designed for medical and clinical settings, including powder-free latex gloves with a protein labeling claim, powdered latex gloves, powdered nitrile gloves, and powder-free nitrile gloves. These products are intended for use in procedures requiring barrier protection, such as patient examinations and medical procedures. The gloves are available in various formulations to accommodate different patient sensitivities and clinical needs.
The portfolio consists of Class I medical devices, which are generally considered low-risk and subject to minimal regulatory oversight. These devices are listed under the FDA’s 510(k) pathway, indicating they have been determined to be substantially equivalent to a legally marketed predicate device. The manufacturer operates from the United States.
Frequently asked questions
How many devices does Ar Alliance Healthcare Sdn. Bhd. have in the registry?
The registry currently lists 4 devices for Ar Alliance Healthcare Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ar Alliance Healthcare Sdn. Bhd.'s devices?
Among its 4 most recently registered devices, Ar Alliance Healthcare Sdn. Bhd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Ar Alliance Healthcare Sdn. Bhd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ar Alliance Healthcare Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ar Alliance Healthcare Sdn. Bhd. in the registry?
The most recently registered devices listed for Ar Alliance Healthcare Sdn. Bhd. include ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS), ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES, NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES and POWDER FREE NITRILE EXAMINATION GLOVES.