New Era Medicare Sdn. Bhd.
MalaysiaFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What New Era Medicare Sdn. Bhd. makes
New Era Medicare Sdn. Bhd. manufactures sterile surgical powder-free latex gloves, designed for single-use in medical procedures to reduce allergic reactions and contamination risks.
The company’s product portfolio is classified under Class I medical devices and is listed via FDA 510(k) clearance in the United States.
Catalogue
Sterile Surgical Powder Free Latex Glove Ref K221424
Regimes: 510(k) Registry: 510(k)
FDA establishments
- New Era Medicare Sdn Bhd Teluk Intan Perak · MY FEI 3021591322
Frequently asked questions
How many devices does New Era Medicare Sdn. Bhd. have in the registry?
The registry currently lists 1 device for New Era Medicare Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list New Era Medicare Sdn. Bhd.'s devices?
Among its 1 most recently registered device, New Era Medicare Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do New Era Medicare Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for New Era Medicare Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from New Era Medicare Sdn. Bhd. in the registry?
The most recently registered devices listed for New Era Medicare Sdn. Bhd. include Sterile Surgical Powder Free Latex Glove.
Which FDA establishments are linked to New Era Medicare Sdn. Bhd.?
1 FDA establishment is linked to New Era Medicare Sdn. Bhd. in the registry; they are listed on the company page.