# K173942: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Central Medicare Sdn Bhd
- Decided: Mar 5, 2018 after 69 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: 5 generations back to K042805 (2004). 6 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172525: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, Central Medicare Sdn Bhd (2017) Summary page 5.

## Most influential descendants
- K182600: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (2018), 13 descendants of its own
- 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

## Indications for use
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs 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 D6978-05 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: Bleomycin Sulfate: 15 mg/ml, >240 minutes Busulfan: 6 mg/ml, >240 minutes Carboplatin: 10 mg/ml, >240 minutes Carmustine: 3.3 mg/ml, 12.4 minutes Cisplatin: 1 mg/ml, >240 minutes Chloroquine: 50 mg/ml, >240 minutes Cyclophosphamide: 20 mg/ml, >240 minutes Cyclosporin: 100 mg/ml, >240 minutes Cytarabine HCI: 100 mg/ml, >240 minutes Dacarbazine: 10 mg/ml, >240 minutes Daunorubicin HCI: 5 mg/ml, >240 minutes Docetaxel: 10 mg/ml, >240 minutes Doxorubicin Hydrochloride: 2 mg/ml, >240 minutes Epirubicin (Ellence): 2 mg/ml, >240 minutes Etoposide: 20 mg/ml, >240 minutes Fludarabine: 25 mg/ml, >240 minutes Fluorouracil: 50 mg/ml, >240 minutes Gemcitabine: 38 mg/ml, >240 minutes Idarubicin: 1 mg/ml, >240 minutes Ifosfamide: 50 mg/ml, >240 minutes Irinotecan: 20 mg/ml, >240 minutes Mechlorethamine HCI: 1 mg/ml, >240 minutes Melphalan: 5 mg/ml, >240 minutes Methotrexate: 25 mg/ml, >240 minutes Mitomycin: 0.5 mg/ml, >240 minutes Mitoxantrone: 2 mg/ml, >240 minutes Oxaliplatin: 5 mg/ml, >240 minutes Paclitaxel: 6 mg/ml, >240 minutes Paraplatin: 10 mg/ml, >240 minutes Retrovir: 10 mg/ml, >240 minutes Rituximab: 10 mg/ml, >240 minutes Thiotepa: 10 mg/ml, 24.4 minutes Topotecane: 1 mg/ml, >240 minutes Trisonex: 1 mg/ml, >240 minutes Velcade: 1 mg/ml, >240 minutes Vincristine Sulfate: 1 mg/ml, >240 minutes *Please note that the following drugs have extremely low permeation times: Carmustine: 12.4 minutes and Thiotepa: 24.4 minutes

Source page: https://510kreport.com/device/K173942
Methodology: https://510kreport.com/methodology