Atlas FDA

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

Shiva Medicare , Ltd. — Predicate Candidate Screening

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

42 daysmedian FDA review time
50 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K984615POWDERED NITRILE EXAMINATION GLOVESShiva Medicare , Ltd.1999-02-17500
K984610POWDER FREE NITRILE EXAMINATION GLOVESShiva Medicare , Ltd.1999-02-09420
K982589SURGEON'S GLOVEShiva Medicare , Ltd.1998-09-10480
K982579LATEX EXAMINATION GLOVES POWDER FREEShiva Medicare , Ltd.1998-08-11180
K982586POWDER FREE SURGEONS GLOVEShiva Medicare , Ltd.1998-08-11180

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