Data / Medical devices / Malaysia / HL Rubber Industries Sdn Bhd
HL Rubber Industries Sdn Bhd: FDA-registered device maker in KUALA PILAH Negeri Sembilan, Malaysia, 9 510(k) clearances
HL Rubber Industries Sdn Bhd is registered with the FDA (registration 9680466) in KUALA PILAH Negeri Sembilan, Malaysia. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680466
- FEI number
- 3006993432
- Address
- Lot 10, Kawasan Perindustrian Dioh, KUALA PILAH Negeri Sembilan, Malaysia, 72000
- Owner or operator
- HL RUBBER INDUSTRIES SDN BHD (9090472)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 25, 2001
- Registered through
- 2026
- Brand names listed
- Black Magic, LYDUS, N GLOVE, Nitrile Examination Gloves, Olivia Claire Health, POWDER-FREE LATEX EXAMINATION GLOVES, NON-STERILE, POWDER-FREE NITRILE, POWDER-FREE NITRILE WHITE AND BLUE EXAMINATION GLOVES and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 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 |
|---|---|---|---|---|---|---|
| May 26, 2022 | K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs | LZC | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| August 26, 2014 | K141021 | POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| July 11, 2014 | K140316 | EXAMINATION GLOVES | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| February 21, 2013 | K130038 | POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| May 20, 2010 | K100369 | POWDER-FREE NITRILE GLOVES, BLACK | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| February 8, 2007 | K063522 | POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| January 23, 2007 | K063524 | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| February 9, 1999 | K984125 | POWDERED LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | Kilang Barangan Getah Dioh | accessdata.fda.gov |
| January 25, 1999 | K984127 | POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | Kilang Barangan Getah Dioh | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Latex Patient Examination Glove
- All makers of Polymer Patient Examination Glove
Updated May 26, 2022. 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.