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

Shijiazhuang Lianhe Shunda Plastic Products Co., L · Predicate Candidate Screening

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

63 daysmedian FDA review time
84 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K070041POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVESShijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-28840
K070027POWDERED (WHITE) VINYL PATIENT EXAMINATIONShijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-22780
K070026POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVESShijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-07630
K070037POWDER FREE VINYL PATIENT EXAMINATION GLOVEShijiazhuang Lianhe Shunda Plastic Products Co., L2007-02-20480
K070046POWDERED VINYL PATIENT GLOVEShijiazhuang Lianhe Shunda Plastic Products Co., L2007-02-07350
K070044POWDER FREE (YELLOW) VINYL PATIENT EXAMINATIONShijiazhuang Lianhe Shunda Plastic Products Co., L2007-01-29260

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