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FDA 510(k) Applications Submitted by HARTALEGA SDN. BHD.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K171874
06/23/2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
HARTALEGA SDN. BHD.
K180505
02/26/2018
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
Hartalega Sdn. Bhd.
K180786
03/26/2018
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
HARTALEGA SDN. BHD.
K200897
04/03/2020
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
Hartalega SDN. BHD.
K161006
04/11/2016
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
HARTALEGA SDN. BHD.
K161008
04/11/2016
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
HARTALEGA SDN. BHD.
K201531
06/08/2020
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega SDN. BHD.
K162491
09/07/2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
HARTALEGA SDN. BHD.
K173137
09/29/2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
Hartalega Sdn. Bhd.
K162818
10/06/2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
HARTALEGA SDN. BHD.
K162819
10/06/2016
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
HARTALEGA SDN. BHD.
K173509
11/13/2017
Biodegradable Nitrile Powder Free Examination Glove (Blue)
Hartalega Sdn. Bhd.
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