Wear Safe Malaysia Sdn. Bhd. is one of 241 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Wear Safe Malaysia Sdn. Bhd. - FDA 510(k) Cleared Devices
Recent clearances: Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim, POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE, POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
14
Total
14
Cleared
0
Denied
Wear Safe Malaysia Sdn. Bhd. has 14 FDA 510(k) cleared general hospital devices. Based in Port Klang, Selangor, D.E., MY.
Historical record: 14 cleared submissions from 1998 to 2017.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Wear Safe (Malaysia) Sdn. Bhd. as regulatory consultant.
FDA 510(k) Regulatory Record - Wear Safe Malaysia Sdn. Bhd.
14 devices
Cleared
Sep 29, 2017
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use...
General Hospital
50d
Cleared
Sep 03, 2010
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH...
General Hospital
67d
Cleared
Jan 19, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE...
General Hospital
68d
Cleared
Oct 21, 2009
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH...
General Hospital
69d
Cleared
May 15, 2009
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN...
General Hospital
126d
Cleared
Apr 03, 2009
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN...
General Hospital
53d
Cleared
Nov 02, 2006
STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH...
General Hospital
35d
Cleared
Oct 27, 2006
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
General Hospital
39d
Cleared
Jan 20, 2000
PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
General Hospital
163d
Cleared
Dec 16, 1999
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
General Hospital
128d
Cleared
Dec 16, 1999
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE
General Hospital
128d
Cleared
Nov 17, 1999
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
General Hospital
99d
Cleared
Oct 21, 1999
SURGEON POWDER-FREE GLOVES, LATEX, STERILE
General Hospital
72d
Cleared
Jan 06, 1998
PATIENT EXAMINATION POWDER-FREE GLOVES
General Hospital
146d