Data / Medical devices / Malaysia / Dynacare Sdn Bhd
Dynacare Sdn Bhd: FDA-registered device maker in Sitiawan Perak, Malaysia, 1 510(k) clearance
Dynacare Sdn Bhd is registered with the FDA (registration 3021641087) in Sitiawan Perak, Malaysia. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021641087
- Address
- Lot 15528 (PT5001) Kawasan Perusahaan Kampung Acheh, Sitiawan Perak, Malaysia, 32000
- Owner or operator
- Dynacare SDN BHD (10084090)
- Roles
- Manufacturer
- First device listed
- December 6, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 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 |
|---|---|---|---|---|---|---|
| January 13, 2023 | K223221 | Non-Sterile Powder Free Nitrile Examination Gloves | LZA | Substantially Equivalent | Dynacare Sdn Bhd | accessdata.fda.gov |
Compare with other makers
Updated January 13, 2023. 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.