Hartalega Sdn Bhd is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Hartalega Sdn Bhd - FDA 510(k) Cleared Devices
Recent clearances: 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, Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue), Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
61
Total
61
Cleared
0
Denied
Hartalega Sdn Bhd has 61 FDA 510(k) cleared general hospital devices. Based in Kuala Lumpur, MY.
Historical record: 61 cleared submissions from 1989 to 2020.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Hartalega Sdn. Nhd and Third Party Review Group, LLC.
FDA 510(k) Regulatory Record - Hartalega Sdn Bhd
61 devices
Cleared
Oct 02, 2020
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram...
General Hospital
98d
Cleared
Aug 05, 2020
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
General Hospital
58d
Cleared
Jun 01, 2020
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs...
General Hospital
59d
Cleared
Nov 16, 2018
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use...
General Hospital
249d
Cleared
Nov 02, 2018
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
General Hospital
221d
Cleared
Aug 17, 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
General Hospital
277d
Cleared
Aug 10, 2018
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
General Hospital
151d
Cleared
Jun 14, 2018
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with...
General Hospital
108d
Cleared
Dec 12, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
General Hospital
74d
Cleared
Oct 12, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin...
General Hospital
111d
Cleared
May 05, 2017
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
General Hospital
108d
Cleared
Feb 08, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
General Hospital
154d
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