Data / Medical devices / Malaysia / Professional Latex Sdn. Bhd.
Professional Latex Sdn. Bhd.: FDA-registered device maker in KAMUNTING Perak, Malaysia, 3 510(k) clearances
Professional Latex Sdn. Bhd. is registered with the FDA (registration 3042956952) in KAMUNTING Perak, Malaysia. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3042956952
- Address
- Lot 14202, Jalan Perusahaan 3, Kawasan Perusahaan Kamunting, KAMUNTING Perak, Malaysia, 34600
- Owner or operator
- Professional Latex Sdn Bhd (10055058)
- Roles
- Manufacturer
- First device listed
- October 23, 2017
- Registered through
- 2026
- Brand names listed
- LZA - Polymer patient examination glove, LZC - Medical Glove, Specialty, OPJ - Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs, Powder Free Latex Examination Glove, Powder Free Nitrile Examination Glove, QDO - Fentanyl and other opioid protection glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| March 30, 2023 | K220088 | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Professional Latex Sdn Bhd | accessdata.fda.gov |
| 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 |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
Updated March 30, 2023. 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.