Hartalega Sdb. Bhd. - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hartalega Sdb. Bhd. General Hospital ✕
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