# K182383: Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue

- Pathway: 510(k) (Traditional)
- Applicant: Yty Industry (Manjung) Sdn Bhd
- Decided: Mar 19, 2019 after 200 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
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time Carboplatin, 10 mg/ml >240 minutes Carmustine 3.3 mg/ml 11.3 minutes Cisplatin (BCNU), 1.0 mg/ml > 240 minutes Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240 minutes Dacarbazine (DTIC), 10.0 mg/ml > 240 minutes Doxorubicin Hydrochloride, 2.0 mg/ml > 240 minutes Etoposide (Toposar), 20.0 mg/ml > 240 minutes Fluorouracil, 50.0 mg/ml > 240 minutes Ifosfamide , 50.0 mg/ml > 240 minutes Methotrexate, 25 mg/ml > 240 minutes Mitomycin C, 0.5 mg/ml > 240 minutes Mitoxantrone, 2 mg/ml > 240 minutes Paclitaxel (Taxol), 6.0 mg/ml > 240 minutes ThioTEPA (10.0 mg/ml) 7.4minutes Vincristine Sulfate, 1.0 mg/ml > 240 minutes The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 minutes

Source page: https://510kreport.com/device/K182383
Methodology: https://510kreport.com/methodology