Data / Medical devices / Malaysia / Professional Latex Sdn Bhd
Professional Latex Sdn Bhd: FDA-registered device maker in Kamunting Perak, Malaysia, 4 510(k) clearances
Professional Latex Sdn Bhd is registered with the FDA (registration 3012924721) in Kamunting Perak, Malaysia. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 6, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012924721
- Address
- Lot 52, Jalan Logam 2, Kamunting Raya Industrial, Kamunting Perak, Malaysia, 34600
- Owner or operator
- Professional Latex Sdn Bhd (10055058)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 23, 2017
- Registered through
- 2026
- Brand names listed
- ALLOGEL, ALLOGEL-BLUEMAX, ALLOGEL-MAGENTA, Powder Free Latex Examination Glove, Powder Free Nitrile Examination Glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| June 6, 2018 | K173053 | POWDER FREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | Professional Latex Sdn Bhd | accessdata.fda.gov |
| September 8, 2017 | K171667 | Powder Free Nitrile Examination Glove | LZA | Substantially Equivalent | Professional Latex Sdn Bhd | accessdata.fda.gov |
| July 24, 2013 | K130667 | POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL | LYY | Substantially Equivalent | Preventive Care, Inc. | accessdata.fda.gov |
| May 13, 2011 | K110102 | POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG | LZA | Substantially Equivalent | Preventive Care, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 6, 2018. 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.