Data / Medical devices / Malaysia / Aamedix Glove Sdn Bhd
Aamedix Glove Sdn Bhd: FDA-registered device maker in Shah Alam Selangor, Malaysia, 1 510(k) clearance
Aamedix Glove Sdn Bhd is registered with the FDA (registration 3017207705) in Shah Alam Selangor, Malaysia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 11, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017207705
- Address
- Unit 19D, Level 19, No.16, Persiaran Setia Dagang, Bandar Setia Alam 40170 Shah Alam, Selangor Darul Ehsan, Shah Alam Selangor, Malaysia, 40170
- Owner or operator
- AAMedix Glove Sdn Bhd (10084933)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- April 16, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment, Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 11, 2022 | K220121 | Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black | LZA | Substantially Equivalent | Aamedix Glove Sdn Bhd | accessdata.fda.gov |
Compare with other makers
Updated April 11, 2022. 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.