# K213325: Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Xinyisheng Medical Technology Co.,Ltd
- Decided: Jan 28, 2022 after 115 days
- Product code: LZC (Medical Glove, Specialty)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Cisplatin,1.0 mg/ml (1,000 ppm) Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) Dacarbazine,10.0 mg/ml (10,000 ppm) Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) Etoposide, 20.0 mg/ml (20,000 ppm) Fluorouracil,50.0 mg/ml (50,000 ppm) Paclitaxel,6.0 mg/ml (6,000 ppm) Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 23.9minutes ThioTepa10.0 mg/ml (10,000 ppm),25.3 minutes WARNING: Do not use Carmustine and Thiotepa

Source page: https://510kreport.com/device/K213325
Methodology: https://510kreport.com/methodology