# K182600: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Better Care Plastic Technology Co., Ltd.
- Decided: Nov 30, 2018 after 70 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: 6 generations back to K042805 (2004). 7 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173942: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, Central Medicare Sdn Bhd (2018) Summary page 5.

## Most influential descendants
- K213440: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs (2022), 5 descendants of its own
- K210944: Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) (2021), 5 descendants of its own
- K223559: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) (2023), 3 descendants of its own
- K231349: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (2023), 2 descendants of its own
- K213227: Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs) (2022), 1 descendant of its own

## Indications for use
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation The following chemicals have been tested with these gloves: Chemotherapy Drug Minimum Breakthrough Detection Time (Minutes) Carmustine(BCNU) (3.3 mg/ml) 11.0 Cisplatin (1mg/ml) >240 Cyclophosphamide (20mg/ml) >240 Dacarbazine (DTIC) (10mg/ml) >240 Doxorubicin Hydrochloride (2mg/ml) >240 Etoposide (Toposar) (20mg/ml) >240 Fluorouracil (50mg/ml) >240 Methotrexate (25mg/ml) >240 Paclitaxel (Taxol) (6mg/ml) >240 Thiotepa (THT) (10mg/ml) 28.8 Bleomycin (15.0mg/ml) >240 Busulfan (6.0mg/ml) >240 Carboplatin, (10.0mg/ml) >240 Chloroquine, (50.0mg/ml) >240 Cyclosporin, (100.0mg/ml) >240 Cytarabine, (100.0mg/ml) >240 Daunorubicin, (5.0mg/ml) >240 Docetaxel, (10.0mg/ml) >240 Epirubicin (Ellence), (2.0mg/ml) >240 Fludarabine, (25.0mg/ml) >240 Gemcitabine (Gemzar) (38.0mg/ml) >240 Idarubicin, (1.0mg/ml) >240 Ifosfamide, (50.0mg/ml) >240 Irinotecan, (20.0mg/ml) >240 Mechlorethamine HCI, (1.0mg/ml) >240 Melphalan, (5.0mg/ml) >240 Mitomycin C, (0.5mg/ml) >240 Mitoxantrone, (2.0mg/ml) >240 Oxaliplatin, (2.0mg/ml) >240 Paraplatin, (10.0mg/ml) >240 Retrovir, (10.0mg/ml) >240 Rituximab, (10.0mg/ml) >240 Topotecan HCL, (1.0mg/ml) >240 Trisonex, (1.0mg/ml) >240 Velcade (Bortezomib), (1.0mg/ml) >240 Vincristine, (1.0mg/ml) >240 * Please note that the following drugs have extremely low permeation times: Carmustine: 11.0 minutes and Thiotepa: 28.8 minutes

Source page: https://510kreport.com/device/K182600
Methodology: https://510kreport.com/methodology