Atlas FDA

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

Innovative Gloves Co;, Ltd. · Predicate Candidate Screening

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

66 daysmedian FDA review time
107 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K111158LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTInnovative Gloves Co;, Ltd.2011-08-101070
K103670NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND Innovative Gloves Co;, Ltd.2011-03-311050
K083908BLACK NITRILE EXAMINATION GLOVESInnovative Gloves Co;, Ltd.2009-03-06660
K021668NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)Innovative Gloves Co;, Ltd.2002-08-12830
K013333LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTInnovative Gloves Co;, Ltd.2001-12-07590
K993567INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PInnovative Gloves Co;, Ltd.2000-01-12830
K993221INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDEREDInnovative Gloves Co;, Ltd.1999-11-05390
K993222INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREEInnovative Gloves Co;, Ltd.1999-11-05390
K993325INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREEInnovative Gloves Co;, Ltd.1999-11-05320

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