Atlas FDA

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

Shijiazhuang Great Vision Plastic Products Co., LT · Predicate Candidate Screening

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

90 daysmedian FDA review time
243 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K102097POWDER FREE VINYL PATIENT EXAMINATION GLOVESShijiazhuang Great Vision Plastic Products Co., LT2010-11-171130
K102093POWDER FREE VINYL PATIENT EXAMINATION GLOVESShijiazhuang Great Vision Plastic Products Co., LT2010-11-03900
K031108SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FRShijiazhuang Great Vision Plastic Products Co., LT2003-09-081530
K021506POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVESShijiazhuang Great Vision Plastic Products Co., LT2002-06-06280
K014077POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVESShijiazhuang Great Vision Plastic Products Co., LT2002-02-04550
K002012SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVESShijiazhuang Great Vision Plastic Products Co., LT2000-08-09370
K002015SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOShijiazhuang Great Vision Plastic Products Co., LT2000-08-09370
K992554SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVESShijiazhuang Great Vision Plastic Products Co., LT2000-03-292430
K992862SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVESShijiazhuang Great Vision Plastic Products Co., LT1999-11-29960
K992555SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVESShijiazhuang Great Vision Plastic Products Co., LT1999-10-14760

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