Careplus (M) Sdn Bhd - FDA 510(k) Cleared Devices
Recent clearances: Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less), Powder Free Nitrile Examination Glove Black and Dual Color White-Blue, Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Careplus (M) Sdn Bhd General Hospital ✕
10 devices
Cleared
Oct 06, 2021
Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
General Hospital
133d
Cleared
Aug 20, 2021
Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
General Hospital
410d
Cleared
Aug 20, 2021
Latex Examination Glove, Powder free with Protein Content Labeling Claim (50...
General Hospital
245d
Cleared
Aug 03, 2021
ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content...
General Hospital
146d
Cleared
Jun 24, 2021
ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content...
General Hospital
112d
Cleared
May 27, 2021
ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content...
General Hospital
248d
Cleared
Jul 24, 2017
NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
General Hospital
285d
Cleared
Feb 25, 2016
LATEX EXAMINATION GLOVE POWDER FREE
General Hospital
168d
Cleared
Feb 09, 2015
POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
General Hospital
131d
Cleared
Jan 16, 2015
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
General Hospital
107d