Pt. Maja Agung Latexindo is one of 6 FDA 510(k) medical device manufacturers from Indonesia in the dataset, ranked by real submission volume.
Pt. Maja Agung Latexindo - FDA 510(k) Cleared Devices
Recent clearances: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
11
Total
11
Cleared
0
Denied
Pt. Maja Agung Latexindo has 11 FDA 510(k) cleared general hospital devices. Based in Indonesia, ID.
Last cleared in 2022. Active since 1990.
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 Shamrock Marketing Co., Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Pt. Maja Agung Latexindo
11 devices
Cleared
May 18, 2022
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy...
General Hospital
288d
Cleared
Feb 23, 2017
Powder Free Nitrile Examination Gloves, Black
General Hospital
310d
Cleared
Aug 28, 2008
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
General Hospital
92d
Cleared
Dec 06, 2006
POWDER FREE LATEX EXAMINATION GLOVES, BLACK
General Hospital
86d
Cleared
Aug 01, 2002
LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
General Hospital
206d
Cleared
Feb 26, 2002
LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL,...
General Hospital
85d
Cleared
Jun 23, 2000
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING...
General Hospital
64d
Cleared
Feb 07, 2000
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
General Hospital
52d
Cleared
Nov 05, 1999
SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5
General Hospital
81d
Cleared
Dec 23, 1998
POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50...
General Hospital
128d
Cleared
Jan 02, 1990
MAL LATEX EXAMINATION GLOVES
General Hospital
42d