Pt. Maja Agung Latexindo

FDA Regulatory Profile

Pt. Maja Agung Latexindo has 0 FDA recalls, 0 inspections, 11 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
May 18, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances11Oct 4, 2026Not statedCurrent
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated…May 18, 2022
K161099Powder Free Nitrile Examination Gloves, BlackFeb 23, 2017
K081488POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILEAug 28, 2008
K062709POWDER FREE LATEX EXAMINATION GLOVES, BLACKDec 6, 2006
K020040LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIMAug 1, 2002
K013996LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGEFeb 26, 2002
K001274LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR…Jun 23, 2000
K994255LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILEFeb 7, 2000
K992752SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5Nov 5, 1999
K982897POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)Dec 23, 1998
K896604MAL LATEX EXAMINATION GLOVESJan 2, 1990