Wembley Rubber Products (M) Sdn Bhd - FDA 510(k) Cleared Devices
Recent clearances: PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED), ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING), CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
61
Total
61
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wembley Rubber Products (M) Sdn Bhd General Hospital ✕
59 devices
Cleared
Mar 12, 1999
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
General Hospital
228d
Cleared
Jan 27, 1999
ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
General Hospital
562d
Cleared
Jan 26, 1999
CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
General Hospital
561d
Cleared
Oct 24, 1997
PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
General Hospital
102d
Cleared
Oct 11, 1996
COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
General Hospital
459d
Cleared
Jul 26, 1996
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
General Hospital
50d
Cleared
Jul 26, 1996
COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
General Hospital
50d
Cleared
Jun 27, 1996
COMFIT
General Hospital
332d
Cleared
May 06, 1996
COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
General Hospital
111d
Cleared
Apr 26, 1996
COMFIT ORTHOPEDIC
General Hospital
88d
Cleared
Apr 26, 1996
COMFIT MICROPTIC
General Hospital
88d
Cleared
Dec 15, 1995
SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES
General Hospital
234d
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