# K232252: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)

- Pathway: 510(k) (Traditional)
- Applicant: Dehai (Shandong) Medical Gloves, Co., Ltd.
- Decided: Nov 28, 2023 after 123 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: 4 generations back to K183287 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230121: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), Careglove Global Sdn. Bhd. (2023) Summary page 5.

## Indications for use
A patient examination 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs and Fentanyl Minimum Breakthrough Detection Time (minutes) Concentration Black Orange *Carmustine 3.3mg/ml (3,300 ppm) 21.6 22.7 Cyclophosphamide 20 mg/ml (20.000 ppm) >240 min. >240 min. Doxorubicin HCl 2 mg/ml (2,000 ppm) >240 min. >240 min. Etoposide 20mg/ml (20,000 ppm) >240 min. >240 min. Fluorouracil 50 mg/ml(S0,000 ppm) >240 min. >240 min. Mitomycin C 50 mg/ml(500 ppm) >240 min. >240 min. Oxaliplatin 5 mg/ml (5,000 ppm) >240 min. >240 min. Paclitaxel 6 mg/ml (6,000 ppm) >240 min. >240 min. *Thiotepa 10 mg/ml (10,000 ppm) 28 37.1 Fentanyl Citrate Injection 100mcg/2mL >240 min. >240 min. *Please note that following drugs have extremely low permeation times: 1. Carmustine (BCNU) 2. Thio Tepa Warning: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K232252
Methodology: https://510kreport.com/methodology