Atlas FDA

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

Shanghai China Star Corp · Predicate Candidate Screening

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

29 daysmedian FDA review time
136 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071072SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EShanghai China Star Corp2007-08-301360
K010247SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVESShanghai China Star Corp2001-02-06110
K003675SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMIShanghai China Star Corp2001-01-09410
K992206POWDER-FREE VINYL PATIENT EXAMINATION GLOVESShanghai China Star Corp1999-07-29290
K992205PRE-POWDERED VINYL PATIENT EXAMINATION GLOVESShanghai China Star Corp1999-07-23230

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