# K102189: Powder Free Nitrle Examination Gloves with Chemotherapy Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Latexx Manufacturing Sdn.Bhd.
- Decided: Mar 14, 2012 after 590 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
Longest line of descent: 1 generation back to K022765 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032444: Nitrile Powder-Free Examination Gloves with Lotion Coating and Use for Chemotherapy, Cardinalhealth (2003) Summary page 1.
- K022765: Nitrile Powder-Free Examination Gloves, Allegiance Healthcare Corp. (2002) Summary page 1.

## Indications for use
The Powder Freea Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between examiner and patient In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows: Test Chemical and Concentration Average Breakthrough Detection Time (minutes) Cisplatin, 1.0 mg/ml : 240 Cyclophosphamide (Cytoxan), 20.0 mg/mI : 240 Cytarabine, 100 mg/rn : 240 Cytovene, 10 mg/mI 240 Dacarbazine (OTIC), 10.0 mg/mI t 240 Docetaxel, 10.0 mg/mI , 4 Doxorubicin Hydrochloride, 2.0 mg/mI : 240 Fluorouracil, 50.0 mg/l t 240 Ifosfamide, 50.0 mg/mI : 240 Mechlorethamine HCI, 1.0 mglml 240 Methotrexate, 25 mg/ml 2t 240 Mitomycin C, 0.5 mg/mI 240 Mitoxantrone, 2 mg/mI 240 Oxaliplatin, Smq/mI 240 Paclitaxel (Taxol), 6.0 mg/mI 240 Vincristine Sulfate, 1.0 mg/mI 240 Vinorelbine, 10 mg/mi :240 Low Permeation Time (minutes) 1.7 Carmustine (BCNU), 3.3 mg/mI ___________________ Please note that the following drug has an extremely low permeation time: Carmustine (8GNU) 1.7(mins)

Source page: https://510kreport.com/device/K102189
Methodology: https://510kreport.com/methodology