Chrysalis Intelligence · Sponsors · Hartalega Sdn Bhd

Hartalega Sdn Bhd

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

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 2 2020-10-02
LZA 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
2020-08-05 K201531 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) LZA
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