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Hartalega Sdn Bhd

61 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs (K201748)Hartalega Sdn Bhd2020-10-02
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K201531)Hartalega Sdn Bhd2020-08-05
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) (K200897)Hartalega Sdn Bhd2020-06-01
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) (K180645)Hartalega Sdn Bhd2018-11-16
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff (K180786)Hartalega Sdn Bhd2018-11-02
Biodegradable Nitrile Powder Free Examination Glove (Blue) (K173509)Hartalega Sdn Bhd2018-08-17
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green (K180644)Hartalega Sdn Bhd2018-08-10
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) (K180505)Hartalega Sdn Bhd2018-06-14
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) (K173137)Hartalega Sdn Bhd2017-12-12
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) (K171874)Hartalega Sdn Bhd2017-10-12
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) (K170152)Hartalega Sdn Bhd2017-05-05
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K162491)Hartalega Sdn Bhd2017-02-08
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) (K162818)Hartalega Sdn Bhd2017-01-09
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs (K162819)Hartalega Sdn Bhd2017-01-09
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove (K161006)Hartalega Sdn Bhd2016-08-04
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) (K160560)Hartalega Sdn Bhd2016-08-04
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE (K161008)Hartalega Sdn Bhd2016-07-28
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K150593)Hartalega Sdn Bhd2015-06-09
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs (K150103)Hartalega Sdn Bhd2015-04-23
Nitrile Powder Free Examination Glove (Blue) (K142588)Hartalega Sdn Bhd2014-12-18
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE (K140050)Hartalega Sdn Bhd2014-09-12
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M (K133953)Hartalega Sdn Bhd2014-05-28
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN (K133956)Hartalega Sdn Bhd2014-05-28
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) (K132006)Hartalega Sdn Bhd2013-11-07
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) (K130473)Hartalega Sdn Bhd2013-07-05
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT (K123368)Hartalega Sdn Bhd2013-05-07
NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U (K120336)Hartalega Sdn Bhd2012-06-25
NITRILE POWDER FREE EXAMINATION GLOVES (K110758)Hartalega Sdn Bhd2011-08-12
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS (K091652)Hartalega Sdn Bhd2009-09-04
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) (K071910)Hartalega Sdn Bhd2007-09-06
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) (K062950)Hartalega Sdn Bhd2006-12-21
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) (K063046)Hartalega Sdn Bhd2006-11-17
BLUE POWDER FREE NITRILE EXAMINATION GLOVES (K052583)Hartalega Sdn Bhd2006-06-14
POWDER FREE STERILE LATEX SURGICAL GLOVES (K052177)Hartalega Sdn Bhd2005-12-09
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) (K051777)Hartalega Sdn Bhd2005-08-12
NITRILE POWDERED EXAMINATION GLOVES (BLUE) (K051778)Hartalega Sdn Bhd2005-07-26
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) (K050277)Hartalega Sdn Bhd2005-06-07
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) (K050214)Hartalega Sdn Bhd2005-03-16
NITRILE POWDERED EXAMINATION GLOVES (WHITE) (K050215)Hartalega Sdn Bhd2005-03-11
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K041391)Hartalega Sdn Bhd2004-07-09
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES (K022671)Hartalega Sdn Bhd2002-11-18
POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K002593)Hartalega Sdn Bhd2000-11-29
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K001959)Hartalega Sdn Bhd2000-07-26
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS (K993760)Hartalega Sdn Bhd2000-05-15
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. (K993722)Hartalega Sdn Bhd1999-11-23
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS (K993725)Hartalega Sdn Bhd1999-11-23
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K991616)Hartalega Sdn Bhd1999-07-14
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K990283)Hartalega Sdn Bhd1999-03-09
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) (K980572)Hartalega Sdn Bhd1998-03-13
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE) (K980318)Hartalega Sdn Bhd1998-03-11
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES (K973778)Hartalega Sdn Bhd1997-12-11
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM) (K973871)Hartalega Sdn Bhd1997-12-11
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES (K963804)Hartalega Sdn Bhd1997-02-10
PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES (K964148)Hartalega Sdn Bhd1997-02-07
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES (K954416)Hartalega Sdn Bhd1996-10-11
POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES (K954221)Hartalega Sdn Bhd1996-05-03
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K954415)Hartalega Sdn Bhd1996-03-12
PATIENT EXAMINATION GLOVES (K945885)Hartalega Sdn Bhd1995-03-23
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929 (K936063)Hartalega Sdn Bhd1994-06-06
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24 (K936062)Hartalega Sdn Bhd1994-06-06
PATIENT EXAMINATION GLOVES (LATEX) (K892104)Hartalega Sdn Bhd1989-05-31

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