Pt. Smartglove Indonesia

FDA Regulatory Profile

Pt. Smartglove Indonesia has 0 FDA recalls, 0 inspections, 12 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Pt. Smartglove Indonesia".

Latest 510(k)
Jul 18, 2014

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances12Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent 510(k) clearances

12 510(k) clearances from Feb 13, 2003 to Jul 18, 2014.

K-NumberDeviceDate
K133699POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVESJul 18, 2014
K101630POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUESep 7, 2010
K101293POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)Jul 1, 2010
K092034POWDER FREE NITRILE EXAMINATION GLOVES, BLACKOct 19, 2009
K041848POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLORAug 20, 2004
K040792POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)Aug 12, 2004
K040791POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)Jun 3, 2004
K030284POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)Mar 25, 2003
K030112POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF…Feb 27, 2003
K030406NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVORFeb 27, 2003
K022814MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)Feb 19, 2003
K022815MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEXFeb 13, 2003

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.