# K163146: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Hongsen Plastics Technology Co, Ltd.
- Decided: Feb 13, 2017 after 96 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: 3 generations back to K042805 (2004). 4 ancestors in all.
41 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141982: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs, Wrp Asia Pacific Sdn. Bhd. (2015) Summary page 7.

## Most influential descendants
- K172525: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2017), 39 descendants of its own
- K173942: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2018), 17 descendants of its own
- K182600: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (2018), 13 descendants of its own
- K180646: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (2018), 9 descendants of its own
- K201390: Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) (2020), 8 descendants of its own

## Indications for use
The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with proposed device. Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Fluorouracil 50.0 mg/ml (50,000 ppm) > 240 Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) > 240 Cyclophosphamid (Cytoxan) 20.0 mg/ml (20,000 ppm) > 240 *Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 45.0 *Thiotepa 10.0 mg/ml (10,000 ppm) 30.0 Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) > 240 Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) > 240 Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) > 240 Cisplatin 1.0 mg/ml (1,000 ppm) > 240 Carboplatin 10.0 mg/ml (10,000 ppm) > 240 Docetaxel 10.0 mg/ml (10,000 ppm) > 240 Ifosfamide 50.0 mg/ml (50,000 ppm) > 240 Irinotecan 20.0 mg/ml (20,000 ppm) > 240 Mechlorethamine HCL 1.0 mg/ml (1,000 ppm) > 240 Methotrexate 25.0 mg/ml (25,000 ppm) > 240 Mitomycin C 0.5 mg/ml (500 ppm) > 240 Mitoxantrone 2.0 mg/ml (2,000 ppm) > 240 Vincristine Sulfate 1.0 mg/ml (1,000 ppm) > 240 * Please note that the following drugs have low permeation times: Carmustine (BCNU): 45 minutes and Thiotepa: 30 minutes

Source page: https://510kreport.com/device/K163146
Methodology: https://510kreport.com/methodology