Data / Medical devices / Malaysia / Wear Safe (malaysia) Sdn. Bhd.-Facility Ii
Wear Safe (malaysia) Sdn. Bhd.-Facility Ii: FDA-registered device maker in Klang Selangor, Malaysia, 1 510(k) clearance
Wear Safe (malaysia) Sdn. Bhd.-Facility Ii is registered with the FDA (registration 3010195579) in Klang Selangor, Malaysia. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 19, 2013. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010195579
- Address
- LOT 63616, PT 54924, NO 3, Jalan Korporat 7C/KU9 Taman Perindustrian Meru, Mukim Kapar, Klang Selangor, Malaysia, 42200
- Owner or operator
- WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II (10043522)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 25, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 19, 2013 | K123469 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE | LZA | Substantially Equivalent | Wear Safe (Malaysia) Sdn Bhd - Facility II | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated February 19, 2013. 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.