Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Maxter Glove Manufacturing Sdn Bhd · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

84 daysmedian FDA review time
342 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K172864Non-Sterile Powder Free Blue Nitrile Examination Gloves TestMaxter Glove Manufacturing Sdn Bhd2018-05-022240
K151390Powder Free Nitrile Examination Gloves Tested For Use With CMaxter Glove Manufacturing Sdn Bhd2016-05-023420
K113100POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CMaxter Glove Manufacturing Sdn Bhd2012-02-061100
K040176MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVESMaxter Glove Manufacturing Sdn Bhd2004-02-24290
K032501MAXTER STERILE POWDER FREE SURGICAL GLOVESMaxter Glove Manufacturing Sdn Bhd2003-10-17650
K032467MAXTER STERILE POWDERED LATEX SURGICAL GLOVESMaxter Glove Manufacturing Sdn Bhd2003-10-10600
K013498CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITMaxter Glove Manufacturing Sdn Bhd2002-01-17870
K013554POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES Maxter Glove Manufacturing Sdn Bhd2002-01-17840
K013443POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MMaxter Glove Manufacturing Sdn Bhd2001-11-29430

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda