Hartalega Sdb. Bhd.

FDA Regulatory Profile

Hartalega Sdb. Bhd. has 0 FDA recalls, 0 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jan 24, 2017

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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) clearances4Oct 4, 2026Not statedCurrent
Inspections0Oct 27, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K162924Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet…Jan 24, 2017
K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less…Dec 20, 2016
K142805Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet…Dec 18, 2014
K142270LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF…Nov 25, 2014