# K171104: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Yty Industry (Manjung) Sdn Bhd
- Decided: Aug 25, 2017 after 134 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: 3 generations back to K090412 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161215: Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs, Brightway Holdings Sdn. Bhd. (2016) Summary page 5.

## Indications for use
A patient examination gloves 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. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below. Tested Chemotherapy Drug And Concentration — Average Breakthrough Detection Time Carboplatin, 10 mg/ml — > 240 minutes Carmustine (3.3 mg/ml) — 15.0 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) — 30.1minutes Vincristine Sulfate, 1.0 mg/ml — > 240 minutes 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 A patient examination gloves 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. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below. Tested Chemotherapy Drug And Concentration — Average Breakthrough Detection Time Carboplatin, 10 mg/ml — > 240 minutes Carmustine (3.3 mg/ml) — 2.4 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) — 1.9 minutes Vincristine Sulfate, 1.0 mg/ml — > 240 minutes The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 2.4 minutes ThioTEPA (10.0 mg/ml): 1.9 minutes

Source page: https://510kreport.com/device/K171104
Methodology: https://510kreport.com/methodology