# K181130: Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Titans Hongsen Medical Technology Co., Ltd.
- Decided: Aug 10, 2018 after 102 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: 4 generations back to K042805 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163146: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs, Hebei Hongsen Plastics Technology Co, Ltd. (2017) Summary page 7.

## Indications for use
The Powder Free Blue Nitrile Examination 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 Bleomycin 15 mg/ml (15,000 ppm) >240 Busulfan 6 mg/ml (6,000 ppm) >240 Carboplatin 10 mg/ml (10,000ppm) >240 Carmustine (BCNU) 3.3 mg/ml (3,300ppm) 8.5 (12.7, 13.4, 8.5) Cisplatin 1.0 mg/ml (1,000ppm) >240 Cyclophosphamide(Cytoxan) 20.0 mg/ml (20,000ppm) >240 Cytarabine 100 mg/ml (100,000ppm) >240 Cytovene 10 mg/ml (10,000ppm) >240 Dacarbazine(DTIC) 10.0 mg/ml (10,000ppm) >240 Daunorubicin 5 mg/ml (5,000ppm) >240 Docetaxel 10.0 mg/ml(10,000ppm) >240 Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) >240 Ellence 2 mg/ml (2,000ppm) >240 Etoposide(Toposar) 20.0 mg/ml(20,000ppm) >240 Fludarabine 25 mg/ml(25,000ppm) >240 Fluorouracil 50 mg/ml(50,000ppm) >240 Gemcitabine (Gemzar) 38 mg/ml(38,000ppm) >240 Idarubicin 1 mg/ml (1,000ppm) >240 Ifosfamide 50.0 mg/ml (50,000ppm) >240 Irinotecan 20.0 mg/ml (20,000ppm) >240 Mechlorethamine HCI 1.0 mg/ml (1,000ppm) >240 Melphalan 5 mg/ml (5,000ppm) >240 Methotrexate 25mg/ml (25,000ppm) >240 Mitomycin C 0.5 mg/ml (500 ppm) >240 Mitoxantrone 2.0 mg/ml(2,000ppm) >240 Oxaliplatin 2.0 mg/ml(2,000ppm) >240 Paclitaxel (Taxol) 6.0 mg/ml(6,000ppm) >240 Rituximab 10 mg/ml(10,000ppm) >240 Thiotepa 10.0 mg/ml (10,000ppm) 36.1 (51.2, 36.1, 45.6) Trisenox 0.1 mg/ml (100ppm) >240 Vincristine Sulfate 1.0 mg/ml (1,000ppm) >240 Vinorelbine 10 mg/ml(10,000ppm) >240 *Please note that the following drugs have low permeation times: Carmustine (BCNU): 8.5 minutes and Thiotepa: 36.1 minutes

Source page: https://510kreport.com/device/K181130
Methodology: https://510kreport.com/methodology