Tekmedic (M) Sdn Bhd - FDA 510(k) Cleared Devices
Recent clearances: POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS, COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE), FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Tekmedic (M) Sdn Bhd General Hospital ✕
11 devices
Cleared
Jan 18, 2013
POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
General Hospital
232d
Cleared
Oct 25, 2012
COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
General Hospital
147d
Cleared
Oct 11, 2012
FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND...
General Hospital
133d
Cleared
Aug 03, 2012
NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
General Hospital
106d
Cleared
Jun 25, 2010
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND...
General Hospital
106d
Cleared
Dec 17, 2001
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
General Hospital
74d
Cleared
Apr 12, 2000
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN &...
General Hospital
54d
Cleared
Feb 07, 2000
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
General Hospital
53d
Cleared
Jul 28, 1997
POWDER-FREE PATIENT EXAMINATION GLOVES
General Hospital
61d
Cleared
Sep 29, 1993
LATEX EXAMINATION GLOVES, POWDER FREE
General Hospital
239d
Cleared
May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
General Hospital
58d