Atlas FDA

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

Smart Glove Corp. Sdn Bhd · Predicate Candidate Screening

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

60 daysmedian FDA review time
104 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K091147POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)Smart Glove Corp. Sdn Bhd2009-07-27980
K082370POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)Smart Glove Corp. Sdn Bhd2008-10-17600
K081466STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUESmart Glove Corp. Sdn Bhd2008-07-30640
K071170POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COSmart Glove Corp. Sdn Bhd2007-09-141400
K063627POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CSmart Glove Corp. Sdn Bhd2007-03-201040
K061724POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE ASmart Glove Corp. Sdn Bhd2006-07-25360
K060726POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WSmart Glove Corp. Sdn Bhd2006-05-25690
K060724POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)Smart Glove Corp. Sdn Bhd2006-05-17610
K050122POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DSmart Glove Corp. Sdn Bhd2005-04-18890
K050598POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WISmart Glove Corp. Sdn Bhd2005-04-07290
K033683SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLORSmart Glove Corp. Sdn Bhd2004-01-08450
K022818MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PSmart Glove Corp. Sdn Bhd2002-09-17220
K021521STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLSmart Glove Corp. Sdn Bhd2002-07-02530
K021013SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FRESmart Glove Corp. Sdn Bhd2002-05-22540
K013727STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIMSmart Glove Corp. Sdn Bhd2001-12-07280
K012853SMART GLOVE STERILE NITRILE EXAM GLOVESmart Glove Corp. Sdn Bhd2001-11-16840
K012856STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLASmart Glove Corp. Sdn Bhd2001-11-16840
K012479STERILE NITRILE SURGICAL GLOVES (POWDERED)Smart Glove Corp. Sdn Bhd2001-09-26550
K011066STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENSmart Glove Corp. Sdn Bhd2001-09-111550
K002568POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROSmart Glove Corp. Sdn Bhd2000-10-03460
K991624POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVESSmart Glove Corp. Sdn Bhd1999-07-09590
K981349SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVESSmart Glove Corp. Sdn Bhd1998-05-18380
K981348SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVESSmart Glove Corp. Sdn Bhd1998-05-18380
K981347SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN Smart Glove Corp. Sdn Bhd1998-05-18380
K974870LATEX EXAMINATION GLOVE POWDER FREESmart Glove Corp. Sdn Bhd1998-03-13740
K974907NITRILE PRE-POWDERED EXAMINATION GLOVESSmart Glove Corp. Sdn Bhd1998-03-13720
K974557SMARTTEXSmart Glove Corp. Sdn Bhd1998-03-13980

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