Data / Medical devices / Malaysia / Nitrilist Gloves Manufacturing Sdn Bhd
Nitrilist Gloves Manufacturing Sdn Bhd: FDA-registered device maker in KUALA PILAH, Negeri Sembilan, Malaysia, 2 510(k) clearances
Nitrilist Gloves Manufacturing Sdn Bhd is registered with the FDA (registration 3010811068) in KUALA PILAH, Negeri Sembilan, Malaysia. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 18, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010811068
- Address
- PT 197,kawasan Perindustrian Dioh, Kuala Pilah, KUALA PILAH, Negeri Sembilan, Malaysia, 72000
- Owner or operator
- Nitrilist Gloves Manufacturing Sdn Bhd (10046405)
- Roles
- Manufacturer
- First device listed
- March 19, 2014
- Registered through
- 2026
- Brand names listed
- Nitrile Examination Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 18, 2013 | K123328 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK | LZA | Substantially Equivalent | Nitrilist Gloves Manufacturing Sdn Bhd | accessdata.fda.gov |
| December 10, 2012 | K122874 | POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE | LZA | Substantially Equivalent | Nitrilist Gloves Manufacturing Sdn Bhd | accessdata.fda.gov |
Compare with other makers
Updated January 18, 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.