Chrysalis Intelligence · Sponsors · Hartalega Sdn Bhd

Hartalega Sdn Bhd

Bandar Sri Damansara, MY · 3 510(k) clearances

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Total clearances
3
2020-06-01 → 2020-10-02
Last 12 months
0
Product codes
2
Most recent
2020-10-02
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KGO Surgeon'S Gloves Class I General, Plastic Surgery 2 2020-10-02
LZA Polymer Patient Examination Glove Class I General Hospital 1 2020-08-05
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2020-10-02 K201748 Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs KGO Class I General, Plastic Surgery
2020-08-05 K201531 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) LZA Class I General Hospital
2020-06-01 K200897 Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) KGO Class I General, Plastic Surgery
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence