Chrysalis Intelligence · Sponsors · Hartalega NGC Sdn. Bhd.

Hartalega NGC Sdn. Bhd.

Sepang, MY · 15 510(k) clearances

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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	Polymer Patient Examination Glove	Class I	General Hospital	11	2026-07-20
KGO	Surgeon'S Gloves	Class I	General, Plastic Surgery	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	Class I	General, Plastic Surgery
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	Class I	General Hospital
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	Class I	General Hospital
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	Class I	General Hospital
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	Class I	General Hospital
2025-01-08	K243818	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)	LZA	Class I	General Hospital
2023-05-17	K223437	Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)	LZA	Class I	General Hospital
2022-11-11	K222225	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)	LZA	Class I	General Hospital
2022-09-24	K221718	Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)	KGO	Class I	General, Plastic Surgery
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	Class I	General, Plastic Surgery
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	Class I	General Hospital
2020-08-05	K201530	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)	LZA	Class I	General Hospital
2020-04-25	K200581	Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)	LZA	Class I	General Hospital
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	Class I	General Hospital