Maxter Glove Manufacturing Sdn Bhd

FDA Regulatory Profile

Maxter Glove Manufacturing Sdn Bhd has 0 FDA recalls, 0 inspections, 9 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
May 2, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances9Oct 4, 2026Not statedCurrent
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K172864Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsMay 2, 2018
K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMay 2, 2016
K113100POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSFeb 6, 2012
K040176MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVESFeb 24, 2004
K032501MAXTER STERILE POWDER FREE SURGICAL GLOVESOct 17, 2003
K032467MAXTER STERILE POWDERED LATEX SURGICAL GLOVESOct 10, 2003
K013554POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50…Jan 17, 2002
K013498CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS…Jan 17, 2002
K013443POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER…Nov 29, 2001