Supermax Glove Manufacturing Sdn Bhd
SUNGAI BULOH Selangor, MY
SUPERMAX GLOVE MANUFACTURING SDN BHD appears in FDA device records in SUNGAI BULOH Selangor, MY. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Supermax Glove Manufacturing Sdn Bhd between 2000 and 2003. The busiest year on record is 2002, with 3. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K024083 | GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR | LZA | Substantially Equivalent | |
| K014230 | STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) | KGO | Substantially Equivalent | |
| K013953 | AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | |
| K013589 | CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA | LYY | Substantially Equivalent | |
| K010198 | STERILE POWDERED LATEX SURGEON GLOVES | KGO | Substantially Equivalent | |
| K000644 | SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9680710 | 3002808252 | SUPERMAX GLOVE MANUFACTURING SDN BHD | LOT 38 & 42, PUTRA INDUSTRIAL PARK, SUNGAI BULOH Selangor 47000 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain