Atlas FDA

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

Wealth on (Jiangsu) Co., Ltd. · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122396POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLOREDWealth on (Jiangsu) Co., Ltd.2013-01-311770
K120584POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVESWealth on (Jiangsu) Co., Ltd.2012-07-101340
K110219POWDER FREE VINYL PATIENT EXAMINATION GLOVESWealth on (Jiangsu) Co., Ltd.2011-04-19840

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