Hartalega Sdb. Bhd. is one of 220 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Hartalega Sdb. Bhd. - FDA 510(k) Cleared Devices
Recent clearances: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
4
Total
4
Cleared
0
Denied
Hartalega Sdb. Bhd. has 4 FDA 510(k) cleared medical devices. Based in Bandar Sri Damansara, MY.
Historical record: 4 cleared submissions from 2014 to 2017. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Hartalega Sdb. Bhd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Hartalega Sdb. Bhd.
4 devices
Cleared
Jan 24, 2017
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
General Hospital
98d
Cleared
Dec 20, 2016
Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim...
General Hospital
260d
Cleared
Dec 18, 2014
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin...
General Hospital
80d
Cleared
Nov 25, 2014
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200...
General Hospital
102d