Atlas FDA

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

Glormed Intl., Inc. · Predicate Candidate Screening

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

41 daysmedian FDA review time
184 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K041945POWDER-FREE BLUE VINYL EXAM GLOVESGlormed Intl., Inc.2004-08-20320
K031104POWDERED VINYL EXAM GLOVES, WHITEGlormed Intl., Inc.2003-06-10640
K021353POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITEGlormed Intl., Inc.2002-06-06410
K002340VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOWGlormed Intl., Inc.2000-08-22210
K983494VINYL EXAM GLOVES, POWDER FREEGlormed Intl., Inc.1998-11-05310
K981360VINYL PATIENT EXAMINATION GLOVE, POWDEREDGlormed Intl., Inc.1998-10-151840

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