Data / Medical devices / Malaysia / Qube Medical Products Sdn Bhd
Qube Medical Products Sdn Bhd: FDA-registered device maker in Rawang Selangor, Malaysia, 2 510(k) clearances
Qube Medical Products Sdn Bhd is registered with the FDA (registration 3009474977) in Rawang Selangor, Malaysia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 29, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009474977
- Address
- No. 9, Jalan KPK 1/3, Kawasan Perindustrian Kundang, Rawang Selangor, Malaysia, 48020
- Owner or operator
- Qube Medical Products Sdn Bhd (10038357)
- Roles
- Manufacturer
- First device listed
- March 13, 2020
- Registered through
- 2026
- Brand names listed
- Powder Free Latex Examination Glove, Powder Free Nitrile Examination Glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 29, 2016 | K153732 | Powder Free Blue Nitrile Examination Glove | LZA | Substantially Equivalent | Qube Medical Product Sdn Bhd | accessdata.fda.gov |
| February 12, 2014 | K123537 | POWDER FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Qube Medical Product Sdn Bhd | accessdata.fda.gov |
Compare with other makers
Updated July 29, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.