DeviceClearance

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) +1 more— 510(k) K260867

Substantially Equivalent

Hartalega NGC Sdn. Bhd.

FDA 510(k) clearance K260867 for Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) +1 more, Substantially Equivalent on 2026-06-17. Applicant: Hartalega NGC Sdn. Bhd.. Device class: 1.

Summary

Hartalega NGC's clearance covers powder-free nitrile examination gloves in blue and black, filed under LZA, polymer patient examination gloves. The device names say both were tested for use with chemotherapy drugs and fentanyl citrate; the record gives no test results.

Class I, 21 CFR 880.6250. 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. Review took 92 calendar days (March 17 to June 17, 2026).

Clearance details

Device name as filed
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)
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
Download summary PDFView on FDA.gov ↗

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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.