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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Besglove Medicare Sdn. Bhd. · Predicate Candidate Screening

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

48 daysmedian FDA review time
77 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K994082POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 Besglove Medicare Sdn. Bhd.2000-01-28560
K993500POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIBesglove Medicare Sdn. Bhd.1999-12-02480
K993495POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MIBesglove Medicare Sdn. Bhd.1999-11-24400
K993502POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 Besglove Medicare Sdn. Bhd.1999-11-24400
K981877NITRILE POWDERFREE EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.1998-08-11750
K981878POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED)Besglove Medicare Sdn. Bhd.1998-08-11750
K981879POWDERED NITRILE EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.1998-08-11750
K982286POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)Besglove Medicare Sdn. Bhd.1998-08-11420
K982284POWDERED GREEN LATEX EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.1998-08-03340
K982285POWDERFREE GREEN LATEX EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.1998-08-03340
K981673POWDERFREE GREEN NITRILE EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.1998-07-28770
K981674POWDERED GREEN NITRILE EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.1998-07-28770
K981675POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)Besglove Medicare Sdn. Bhd.1998-07-28770
K980939SAFETY POWDERED BLUE LATEX EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.1998-04-03220
K980940SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVESBesglove Medicare Sdn. Bhd.1998-04-03220
K980941SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COABesglove Medicare Sdn. Bhd.1998-04-03220
K980167POWDERFREE LATEX EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.1998-03-13560
K980194POWDERFREE LATEX EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.1998-03-13520
K980275POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED)Besglove Medicare Sdn. Bhd.1998-03-13460
K980280POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)Besglove Medicare Sdn. Bhd.1998-03-13460
K980285POWDERFREE BLUE NITRILE EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.1998-03-13460
K971629PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED)Besglove Medicare Sdn. Bhd.1997-08-06960

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