Data / Medical devices / Malaysia / Pentavest Holdings Sdn Bhd
Pentavest Holdings Sdn Bhd: FDA-registered device maker in Batu Melaka, Malaysia, 2 510(k) clearances
Pentavest Holdings Sdn Bhd is registered with the FDA (registration 3021915797) in Batu Melaka, Malaysia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021915797
- Address
- No. 9574-9578, Jalan PTB 2, Kawasan Perindustrian Tangga, Batu Melaka, Malaysia, 76400
- Owner or operator
- Pentavest Holdings Sdn Bhd (10084568)
- Roles
- Manufacturer
- First device listed
- March 7, 2022
- Registered through
- 2026
- Brand names listed
- George glove, Penta Glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 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 6, 2022 | K212847 | Penta Glove | LZA | Substantially Equivalent | Pentavest Holdings Sdn Bhd | accessdata.fda.gov |
| December 27, 2021 | K212848 | Sterile Latex Surgical Gloves Powder Free | KGO | Substantially Equivalent | Pentavest Holdings Sdn Bhd | accessdata.fda.gov |
Compare with other makers
Updated January 6, 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.