Atlas FDA

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

Pt.Shamrock Manufacturing Corp. · Predicate Candidate Screening

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

40 daysmedian FDA review time
70 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081040POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LPt.Shamrock Manufacturing Corp.2008-05-20390
K052709POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LPt.Shamrock Manufacturing Corp.2005-11-08400
K052382POWDER FREE NITRILE EXAMINATION GLOVES, BLUEPt.Shamrock Manufacturing Corp.2005-09-15160
K030325POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUMPt.Shamrock Manufacturing Corp.2003-03-28560
K030134LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIPt.Shamrock Manufacturing Corp.2003-03-25700
K030560POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPEPt.Shamrock Manufacturing Corp.2003-03-21280
K011712LATEX EXAMINATION GLOVES- POWDER FREE, BLUEPt.Shamrock Manufacturing Corp.2001-07-17430

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