Medical Device Manufacturer · MY , Malaysia

Sri Johani Sdn. Bhd. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1989
23
Total
23
Cleared
0
Denied

FDA 510(k) Regulatory Record - Sri Johani Sdn. Bhd. General Hospital

23 devices
1-23 of 23
Cleared Dec 03, 1999
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM -...
K993454 · LYY
General Hospital · 51d
Cleared Dec 02, 1999
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR...
K993457 · LYY
General Hospital · 50d
Cleared Nov 10, 1999
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
K993458 · LYY
General Hospital · 28d
Cleared Apr 21, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981039 · LZA
General Hospital · 33d
Cleared Feb 09, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K980037 · LYY
General Hospital · 35d
Cleared Feb 09, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K980038 · LYY
General Hospital · 35d
Cleared Feb 09, 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K980039 · LYY
General Hospital · 35d
Cleared Jan 30, 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K974886 · LZA
General Hospital · 31d
Cleared Jan 29, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K974887 · LZA
General Hospital · 30d
Cleared Dec 18, 1997
POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974183 · LZA
General Hospital · 42d
Cleared Dec 18, 1997
HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR)
K974184 · LYY
General Hospital · 42d
Cleared Dec 18, 1997
POLYMER NITRILE EXAMINATION GLOVES
K974185 · LZA
General Hospital · 42d
Cleared Dec 17, 1997
POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K973903 · LZA
General Hospital · 64d
Cleared Dec 17, 1997
POLYMER LATEX EXAMINATION GLOVES
K973904 · LYY
General Hospital · 64d
Cleared Dec 17, 1997
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974182 · LZA
General Hospital · 41d
Cleared Nov 21, 1997
HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973801 · LYY
General Hospital · 46d
Cleared Nov 21, 1997
HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973815 · LYY
General Hospital · 45d
Cleared Nov 07, 1997
PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)
K973058 · LZA
General Hospital · 81d
Cleared Nov 07, 1997
PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K973059 · LZA
General Hospital · 81d
Cleared Jan 02, 1995
POWDERFREE LATEX EXAMINATION GLOVE
K945247 · LYY
General Hospital · 67d
Cleared Mar 09, 1990
STERILE LATEX EXAMINATION GLOVE
K900868 · LYY
General Hospital · 14d
Cleared Mar 09, 1990
NON-STERILE LATEX PROCEDURE GLOVE
K900869 · LYY
General Hospital · 14d
Cleared Mar 29, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891378 · LYY
General Hospital · 20d
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