Atlas FDA

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

Pt. Medisafe Technologies · Predicate Candidate Screening

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

119 daysmedian FDA review time
340 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201774Polychloroprene Powder Free Sterile Surgical Gloves, Low DerPt. Medisafe Technologies2020-09-16790
K182176Polychloroprene Powder Free Sterile Surgical Gloves, White, Pt. Medisafe Technologies2019-03-282300
K173258Polychloroprene Powder Free Sterile Surgical Gloves, White, Pt. Medisafe Technologies2018-04-201920
K163041Powder Free Polychloroprene Examination Gloves-Pink with AloPt. Medisafe Technologies2017-02-221140
K142941Powder-Free Polyisoprene Sterile Surgical Gloves in White CoPt. Medisafe Technologies2015-11-023891
K142190Polychloroprene Powder-free Surgical Glove (White) Tested foPt. Medisafe Technologies2015-07-143400
K133689POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- Pt. Medisafe Technologies2014-07-032130
K112654POWDERFREE POLYISOPRENE SURGICAL GLOVESPt. Medisafe Technologies2012-02-171580
K102623BLUE POWDERFREE NITRILE EXAMINATION GLOVEPt. Medisafe Technologies2011-06-062660
K102620POWDERFREE BLACK NITRILE EXAMINATION GLOVESPt. Medisafe Technologies2010-11-22700
K082302POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LAPt. Medisafe Technologies2008-12-091190
K050968POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVESPt. Medisafe Technologies2005-07-12850
K042567POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH APt. Medisafe Technologies2005-01-131140
K041913POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATPt. Medisafe Technologies2004-12-011390
K040607MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE Pt. Medisafe Technologies2004-04-22450
K033086NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENTPt. Medisafe Technologies2004-02-261500
K030228POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVESPt. Medisafe Technologies2003-03-14510
K010483POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREPt. Medisafe Technologies2001-05-03720
K010486POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENPt. Medisafe Technologies2001-04-10490

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