Data / Medical devices / Accessory, Surgical Apparel / Malaysia
FDA-registered makers of Accessory, Surgical Apparel in Malaysia: 8 establishments
8 establishments in Malaysia are registered with the FDA to make Accessory, Surgical Apparel (product code LYU). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Accessory, Surgical Apparel
- Product code
- LYU
- Country
- Malaysia
Makers of Accessory, Surgical Apparel in Malaysia
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bergamot Sdn Bhd | KAJANG Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cross Protection M Sdn Bhd | Klang Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dispo-Med (malaysia) Sdn Bhd | Shah Alam Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&y Safety (M) Sdn. Bhd. | SHAH ALAM Selangor, Malaysia | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jingxin Group (M) Sdn Bhd | Kulai Johor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jingxin Group (M) Sdn Bhd | Kulai Johor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L Well Medtech Solutions Sdn. Bhd. | Nibong Tebal Pulau Pinang, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maple Tree Medical Devices Sdn Bhd | Johor Bahru, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.