Data / Medical devices / Malaysia / Maxter Glove Manufacturing Sdn Bhd
Maxter Glove Manufacturing Sdn Bhd: FDA-registered device maker in KLANG Selangor, Malaysia, 8 510(k) clearances
Maxter Glove Manufacturing Sdn Bhd is registered with the FDA (registration 3003699698) in KLANG Selangor, Malaysia. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 2, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003699698
- Address
- Lot 6070, Jalan Haji Abdul Manan, 6TH Miles Off Jalan Meru, KLANG Selangor, Malaysia, 41050
- Owner or operator
- MAXTER GLOVE MANUFACTURING SDN BHD (9048135)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 4, 2007
- Registered through
- 2026
- Brand names listed
- AURELIA, MAXTER, Maxter
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 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 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 |
|---|---|---|---|---|---|---|
| May 2, 2018 | K172864 | Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| February 6, 2012 | K113100 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| February 24, 2004 | K040176 | MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES | LZA | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| October 17, 2003 | K032501 | MAXTER STERILE POWDER FREE SURGICAL GLOVES | KGO | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| October 10, 2003 | K032467 | MAXTER STERILE POWDERED LATEX SURGICAL GLOVES | KGO | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| January 17, 2002 | K013554 | POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| January 17, 2002 | K013498 | CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| November 29, 2001 | K013443 | POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 | LYY | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Latex Patient Examination Glove
Updated May 2, 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.