# K221747: Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Fitone Latex Products Co., Ltd. Guangdong
- Decided: Dec 1, 2022 after 168 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: 5 generations back to K160562 (2016). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211220: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Guangdong Kingfa Sci. & Tech.Co., Ltd. (2021) Summary page 5.

## Indications for use
The nitrile examination glove is intended to be worn on the examiner’s hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carboplatin, 10 mg/ml >240 min. Carmustine (BCNU), 3.3 mg/ml 27.5 min Cisplatin, 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes; Thio Tepa 10.0 mg/ml 88.2 Minutes. Warning: Please do not use with Carmustine and Thio Tepa.

Source page: https://510kreport.com/device/K221747
Methodology: https://510kreport.com/methodology