Atlas FDA

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

Eci Medical Technologies, Inc. · Predicate Candidate Screening

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

73 daysmedian FDA review time
292 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K021598ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVEEci Medical Technologies, Inc.2002-06-10260
K020918ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVEEci Medical Technologies, Inc.2002-04-19290
K984337ELASTYLON POWDER-FREE SURGICAL GLOVEEci Medical Technologies, Inc.1999-04-091270
K971471ELASTYREN POWDER-FREE SURGICAL GLOVEEci Medical Technologies, Inc.1998-02-092920
K970015ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVESEci Medical Technologies, Inc.1997-06-241730
K954533ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVESEci Medical Technologies, Inc.1995-12-11730
K954535ELASTYREN HYPOALLERGENIC SURGICAL GLOVESEci Medical Technologies, Inc.1995-12-11730
K946291ELASTYREN(R) PATIENT EXAMINATION GLOVESEci Medical Technologies, Inc.1995-02-14490
K945833ELASTYREN(R) SURGICAL GLOVESEci Medical Technologies, Inc.1995-01-17490

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