Maxter Glove Manufacturing Sdn Bhd
KLANG Selangor, MY
MAXTER GLOVE MANUFACTURING SDN BHD appears in FDA device records in KLANG Selangor, MY. FDA records list 9 510(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 9 510(k) clearances for Maxter Glove Manufacturing Sdn Bhd between 2001 and 2018. The busiest year on record is 2002, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2012 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172864 | Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | |
| K151390 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs | LZC | Substantially Equivalent | |
| K113100 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | |
| K040176 | MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K032501 | MAXTER STERILE POWDER FREE SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K032467 | MAXTER STERILE POWDERED LATEX SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K013554 | POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K013498 | CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K013443 | POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003699698 | 3003699698 | MAXTER GLOVE MANUFACTURING SDN BHD | LOT 6070, JALAN HAJI ABDUL MANAN,, KLANG Selangor 41050 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