Atlas FDA

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

Tekmedic (M) Sdn Bhd · Predicate Candidate Screening

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

106 daysmedian FDA review time
232 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121592POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTekmedic (M) Sdn Bhd2013-01-182320
K121594COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)Tekmedic (M) Sdn Bhd2012-10-251470
K121591FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VTekmedic (M) Sdn Bhd2012-10-111330
K121192NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)Tekmedic (M) Sdn Bhd2012-08-031060
K100694COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLTekmedic (M) Sdn Bhd2010-06-251061
K013317TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRTekmedic (M) Sdn Bhd2001-12-17740
K000555TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVETekmedic (M) Sdn Bhd2000-04-12540
K994250TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CTekmedic (M) Sdn Bhd2000-02-07530
K971949POWDER-FREE PATIENT EXAMINATION GLOVESTekmedic (M) Sdn Bhd1997-07-28610
K930602LATEX EXAMINATION GLOVES, POWDER FREETekmedic (M) Sdn Bhd1993-09-292390
K892094PATIENT EXAMINATION GLOVES (LATEX)Tekmedic (M) Sdn Bhd1989-05-31580

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