Atlas FDA

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

Koon Seng Sdn Bhd · Predicate Candidate Screening

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

78 daysmedian FDA review time
307 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K212613Powder Free Nitrile Examination Gloves, Non-sterile,Tested FKoon Seng Sdn Bhd2021-12-211250
K171171KS Medicare Powder Free Nitrile Examination Gloves, Non-sterKoon Seng Sdn Bhd2018-02-223070
K110960ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FRKoon Seng Sdn Bhd2011-07-141000
K093375KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WKoon Seng Sdn Bhd2009-12-02340
K013537ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIKoon Seng Sdn Bhd2001-12-07450
K012714ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION Koon Seng Sdn Bhd2001-10-31780
K891821PATIENT EXAMINATION GLOVES (LATEX)Koon Seng Sdn Bhd1989-05-31680

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