# K220644: Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Yty Industry (Manjung) Sdn Bhd
- Decided: Mar 25, 2023 after 386 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
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
A Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient. This glove has also been tested for use with Chemotherapy Drugs. Tested Chemotherapy Drug and Concentration Min Breakthrough Detection Time (minutes) Carboplatin, 10 mg/ml >240 Carmustine, 3.3 mg/ml 15.0 Cisplatin (BCNU), 1.0 mg/ml >240 Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 Dacarbazine (DTIC), 10.0 mg/ml >240 Doxorubicin Hydrochloride, 2.0 m/ml >240 Etoposide (Toposar), 20.0 mg/ml >240 Fluorouracil, 5.0 mg/ml >240 Ifosfamide, 50.0 mg/ml >240 Methotrexate, 25 mg/ml >240 MitomycinC, 0.5mg/ml >240 Mitoxantrone, 2 mg/ml >240 Paclitaxel (Taxol), 6.0 mg/ml >240 ThioTEPA, 10.0 mg/ml 30.1 Vincristine Sulfate, 1.0 mg/ml >240 The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 15.0 minutes, Thiotepa (10.0 mg/ml): 30.1 minutes WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA

Source page: https://510kreport.com/device/K220644
Methodology: https://510kreport.com/methodology