Careplus (M) Sdn Bhd

FDA Regulatory Profile

Careplus (M) Sdn Bhd has 0 FDA recalls, 0 inspections, 10 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Oct 6, 2021

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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) clearances10Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)Oct 6, 2021
K201857Powder Free Nitrile Examination Glove Black and Dual Color White-BlueAug 20, 2021
K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total…Aug 20, 2021
K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50…Aug 3, 2021
K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2…Jun 24, 2021
K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50…May 27, 2021
K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTJul 24, 2017
K152593LATEX EXAMINATION GLOVE POWDER FREEFeb 25, 2016
K142858POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)Feb 9, 2015
K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Jan 16, 2015