Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue +3 more— 510(k) K254285
Substantially EquivalentHartalega NGC Sdn. Bhd.
FDA 510(k) clearance K254285 for Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue +3 more, Substantially Equivalent on 2026-07-20. Applicant: Hartalega NGC Sdn. Bhd.. Device class: 1.
Summary
Hartalega NGC's clearance covers nitrile powder-free examination gloves in four colors: Aqua Blue, Violet Blue, Dark Blue, and Dark Violet Blue. The names say they're tested for use with chemotherapy drugs, but the record doesn't list the drugs or give results.
Class I, 21 CFR 880.6250, filed under LZA, polymer patient examination gloves. General Hospital is both the classification panel and the review panel, and it came in as a Special 510(k).
Hartalega filed from Sepang, Malaysia. The decision came 201 calendar days after FDA received it (December 31, 2025 to July 20, 2026).
Clearance details
- Device name as filed
- 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
- Applicant
- Hartalega NGC Sdn. Bhd.
- Product code
- Product code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sepang, MY
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More clearances from Hartalega NGC Sdn. Bhd.
view all- K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
- K260867 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) +1 more
- K250861 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
- K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) +1 more
- K243818 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.