# K242936: Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Sunray Medical Products, Inc.
- Decided: Jan 15, 2025 after 112 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: 3 generations back to K183287 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240545: GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL), Genabio Diagnostics, Inc. (2024) Summary page 6.

## Indications for use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The glove was tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2023) The following chemicals have been tested with these gloves: Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Blue Black Carmustine 3.3 mg/ml (3,300 ppm) 14.7, Do not use 22.6, Do not use Cisplatin lmg/ml (1,000 ppm) >240 >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 >240 Dacarbazine 10 mg/ml (10,000 ppm) >240 >240 Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 >240 Etoposide, 20 mg/ml (20,000 ppm) >240 >240 Fluorouracil, 50mg/ml (50,000ppm) >240 >240 Methotrexate, 25mg/ml (25,000ppm) >240 >240 Paclitaxel, 6mg/ml (6,000ppm) >240 >240 Thiotepa, 10mg/ml (10,000ppm) 36.4, Do not use 35.6, Do not use Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes Blue Black Fentanyl Citrate Injection, 100mcg/2mg >240 >240 *Please note that the following drugs have extremely low permeation times: Carmustine: 14.7 minutes, Thio Tepa: 36.4 minutes (Blue); Carmustine: 22.6 minutes, Thio Tepa: 35.6 minutes (Black); Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K242936
Methodology: https://510kreport.com/methodology