Atlas FDA

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

General Gloves Corp. · Predicate Candidate Screening

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

62 daysmedian FDA review time
78 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K024338POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDEGeneral Gloves Corp.2003-03-03660
K024174NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVESGeneral Gloves Corp.2003-01-28410
K010830POWDER FREE TEXTURED VINYL EXAMINATION GLOVESGeneral Gloves Corp.2001-04-09200
K010829POWDER FREE ELASTIC VINYL EXAMINATION GLOVESGeneral Gloves Corp.2001-04-05160
K992107BALDUR BRAND VINYL POWDERED EXAMINATION GLOVESGeneral Gloves Corp.1999-08-23620
K982933VINYL EXAMINATION GLOVES, POWDER FREEGeneral Gloves Corp.1998-11-06780

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