Chrysalis Intelligence · Sponsors · Hartalega NGC Sdn. Bhd.

Hartalega NGC Sdn. Bhd.

Sepang, MY · 15 510(k) clearances

Total clearances
15
2020-04-06 → 2026-07-28
Last 12 months
4
Product codes
3
Most recent
2026-07-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LZA 11 2026-07-20
KGO 3 2026-07-28
OPC Powder-Free Polychloroprene Patient Examination Glove Class I General Hospital 1 2021-08-03
Filings

All 510(k) clearances (15)

Date K-number Device Code Class Specialty
2026-07-28 K260558 Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate KGO
2026-07-20 K254285 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue LZA
2026-06-17 K260867 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) LZA
2025-10-23 K250861 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) LZA
2025-07-30 K251319 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff LZA
2025-01-08 K243818 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) LZA
2023-05-17 K223437 Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) LZA
2022-11-11 K222225 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) LZA
2022-09-24 K221718 Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) KGO
2022-05-26 K214074 Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs KGO
2021-08-03 K211758 Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) OPC Class I General Hospital
2020-08-25 K201772 Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) LZA
2020-08-05 K201530 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) LZA
2020-04-25 K200581 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) LZA
2020-04-06 K200019 Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) LZA