# K101828: Powder Free Latex Examination Gloves (18 ML), Blue Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Gx Corporation Sdn Bhd
- Decided: Oct 4, 2010 after 95 days
- Product code: LYY (Latex 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
This glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner. Chemotherapy Drug Permeation (Average Breakthrough Detection Time in Minutes) Thiotepa (10.0 mg / ml) 7.71 Carmustine (BCNU) (3.3 mg I ml) 63.03 Dacarbazine (DTIC) (10.0 mg I ml) > 240 Cyclophosphamide (Cytoxan) (20.0 mg Iml) > 240. Doxorubicin Hydrochloride (2.0 mg Iml) > 240 Fluorouracil (50.0 mg I mI4 > 240 Cisplatin (1.0 mg I ml) > 240 Etoposide (Toposar) (20.0 mg I ml) > 240 Paclitaxel (Taxol) (6.0 mg Iml) > 240 Ifosfamide. (50.0 mg I ml). > 240 Methotrexate (25.0 mg I ml) > 240 Mitomycin 0 (0.5 mg Iml) >240 Mitoxantrone (2.0 mg Iml) > 240 Vincristine Sulfate (1.0mng / ml) >'240 Please note that Thiotepa has an extremely low permeation time of less than 30 minutes

Source page: https://510kreport.com/device/K101828
Methodology: https://510kreport.com/methodology