Data / Medical devices / Malaysia / Supermax Glove Manufacturing Sdn Bhd
Supermax Glove Manufacturing Sdn Bhd: FDA-registered device maker in SUNGAI BULOH Selangor, Malaysia, 13 510(k) clearances
Supermax Glove Manufacturing Sdn Bhd is registered with the FDA (registration 9680710) in SUNGAI BULOH Selangor, Malaysia. It lists 3 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 10, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680710
- FEI number
- 3002808252
- Address
- Lot 38 & 42, Putra Industrial Park Bukit Rahman Putra, SUNGAI BULOH Selangor, Malaysia, 47000
- Owner or operator
- SUPERMAX GLOVE MANUFACTURING SDN BHD. (9010828)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 30, 2007
- Registered through
- 2026
- Brand names listed
- AURELIA, Aurelia, FANTASTIK, Fantastik, HIGH-MAX, KING, King, MEDIC DENT and more
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 | 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 |
|---|---|---|---|---|---|---|
| January 10, 2003 | K024083 | GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR | LZA | Substantially Equivalent | Supermax Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| March 13, 2002 | K014230 | STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) | KGO | Substantially Equivalent | Supermax Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| March 5, 2002 | K013774 | CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA | LZA | Substantially Equivalent | Supermax Sdn Bhd | accessdata.fda.gov |
| February 26, 2002 | K013953 | AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | Supermax Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| January 8, 2002 | K013589 | CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA | LYY | Substantially Equivalent | Supermax Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| February 23, 2001 | K010198 | STERILE POWDERED LATEX SURGEON GLOVES | KGO | Substantially Equivalent | Supermax Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| January 20, 2000 | K993865 | GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Supermax Sdn Bhd | accessdata.fda.gov |
| January 20, 2000 | K993864 | COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Supermax Sdn Bhd | accessdata.fda.gov |
| October 27, 1999 | K993258 | SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Supermax Sdn Bhd | accessdata.fda.gov |
| May 26, 1999 | K991415 | SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Supermax Sdn Bhd | accessdata.fda.gov |
| July 22, 1998 | K980966 | SUPERGLOVES POWDERED NITRILE | LZA | Substantially Equivalent | Supermax Sdn Bhd | accessdata.fda.gov |
| June 9, 1998 | K980494 | SUPERGLOVES | LYY | Substantially Equivalent | Supermax Sdn Bhd | accessdata.fda.gov |
| March 13, 1998 | K980071 | SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Supermax Latex Products Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Surgeon'S Gloves
- All makers of Polymer Patient Examination Glove
Updated January 10, 2003. 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.