# K261793: Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)

- Pathway: 510(k) (Traditional)
- Applicant: Maxter Healthcare, Inc.
- Decided: Sep 9, 2026 after 103 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K160562 (2016). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213040: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs,  Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs, Guangdong Kingfa Sci. & Tech.Co., Ltd. (2022) Summary page 9.

## Indications for use
The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue Color), are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove. In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Re-approved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black Color), are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove. In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Re-approved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs

Source page: https://510kreport.com/device/K261793
Methodology: https://510kreport.com/methodology