Atlas FDA

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

Hartalega Sdn Bhd — Predicate Candidate Screening

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

108 daysmedian FDA review time
221 days90th percentile
61clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201748Latex Powder Free Surgical Glove with Protein Labelling ClaiHartalega Sdn Bhd2020-10-02980
K201531Sterile Nitrile Powder Free Examination Glove Tested for UseHartalega Sdn Bhd2020-08-05580
K200897Polyisoprene Powder Free Surgical Underglove for Use with ChHartalega Sdn Bhd2020-06-01590
K180645Powder Free Examination Gloves with Colloidal Oatmeal USP anHartalega Sdn Bhd2018-11-162490
K180786Sterile Nitrile Powder Free Examination Glove Tested for UseHartalega Sdn Bhd2018-11-022210
K173509Biodegradable Nitrile Powder Free Examination Glove (Blue)Hartalega Sdn Bhd2018-08-172770
K180644Nitrile Powder Free Examination Gloves with Colloidal OatmeaHartalega Sdn Bhd2018-08-101510
K180505Nitrile Powder Free Examination Glove with Colloidal OatmealHartalega Sdn Bhd2018-06-141080
K173137Nitrile Powder Free Examination Glove Tested for Use with ChHartalega Sdn Bhd2017-12-12740
K171874Nitrile Powder Free Examination Glove with Colloidal OatmealHartalega Sdn Bhd2017-10-121110
K170152POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)Hartalega Sdn Bhd2017-05-051080
K162491Nitrile Powder Free Examination Glove with Low Dermatitis PoHartalega Sdn Bhd2017-02-081540
K162818Nitrile Powder Free Examination Glove with Low Dermatitis PoHartalega Sdn Bhd2017-01-09950
K162819Nitrile Powder Free Examination Glove with Colloidal OatmealHartalega Sdn Bhd2017-01-09950
K161006Latex Powder Free Polymer Coated Examination Glove with ProtHartalega Sdn Bhd2016-08-041150
K160560Nitrile Powder Free Examination Glove with Low Dermatitis PoHartalega Sdn Bhd2016-08-041570
K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE PHartalega Sdn Bhd2016-07-281080
K150593Nitrile Powder Free Examination Glove with Low Dermatitis PoHartalega Sdn Bhd2015-06-09920
K150103Nitrile Powder Free Examination Gloves (Orange) Tested For UHartalega Sdn Bhd2015-04-23930
K142588Nitrile Powder Free Examination Glove (Blue)Hartalega Sdn Bhd2014-12-18940
K140050NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEALHartalega Sdn Bhd2014-09-122460
K133953LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL Hartalega Sdn Bhd2014-05-281560
K133956NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEALHartalega Sdn Bhd2014-05-281560
K132006STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE Hartalega Sdn Bhd2013-11-071290
K130473NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)Hartalega Sdn Bhd2013-07-051330
K123368LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL Hartalega Sdn Bhd2013-05-071870
K120336NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE Hartalega Sdn Bhd2012-06-251430
K110758NITRILE POWDER FREE EXAMINATION GLOVESHartalega Sdn Bhd2011-08-121470
K091652NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE Hartalega Sdn Bhd2009-09-04870
K071910NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDEHartalega Sdn Bhd2007-09-06570
K062950POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)Hartalega Sdn Bhd2006-12-21830
K063046NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)Hartalega Sdn Bhd2006-11-17440
K052583BLUE POWDER FREE NITRILE EXAMINATION GLOVESHartalega Sdn Bhd2006-06-142670
K052177POWDER FREE STERILE LATEX SURGICAL GLOVESHartalega Sdn Bhd2005-12-091210
K051777NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)Hartalega Sdn Bhd2005-08-12420
K051778NITRILE POWDERED EXAMINATION GLOVES (BLUE)Hartalega Sdn Bhd2005-07-26250
K050277CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)Hartalega Sdn Bhd2005-06-071200
K050214NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)Hartalega Sdn Bhd2005-03-16440
K050215NITRILE POWDERED EXAMINATION GLOVES (WHITE)Hartalega Sdn Bhd2005-03-11390
K041391FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVESHartalega Sdn Bhd2004-07-09450
K022671FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVESHartalega Sdn Bhd2002-11-18980
K002593POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROHartalega Sdn Bhd2000-11-291000
K001959POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT Hartalega Sdn Bhd2000-07-26290
K993760POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELHartalega Sdn Bhd2000-05-151890
K993722BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PHartalega Sdn Bhd1999-11-23200
K993725GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH Hartalega Sdn Bhd1999-11-23200
K991616CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEINHartalega Sdn Bhd1999-07-14650
K990283BLUE POWDER-FREE NITRILE EXAMINATION GLOVESHartalega Sdn Bhd1999-03-09390
K980572POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CHartalega Sdn Bhd1998-03-13240
K980318POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)Hartalega Sdn Bhd1998-03-11430

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