# K171873: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Zhonghong Pulin Medical Products Co., Ltd.
- Decided: Nov 15, 2017 after 145 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: 2 generations back to K090412 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151750: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Kossan International Sdn Bhd (2016) Summary page 4.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (BCNU) 3.3 mg/ml 14.7 Cisplatin 1.0 mg/ml >240 Cyclophosphamide (Cytoxan) 20 mg/ml >240 Cytarabine 100 mg/ml >240 Dacarbazine (DTIC) 10.0 mg/ml >240 Doxorubicin Hydrochloride 2.0 mg/ml >240 Etoposide (Toposar) 20.0 mg/ml >240 Fluorouracil 50.0 mg/ml >240 Ifosfamide 50.0 mg/ml >240 Methotrexate 25 mg/ml >240 Mitomycin C 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 Paclitaxel (Taxol) 6.0 mg/ml >240 Thiotepa 10.0 mg/ml 58.8 Vincristine Sulfate 1.0 mg/ml >240 Please note the following drugs have extremely low permeation times: Carmustine (BCNU) (3.3mg/ml) 14.7 minutes and Thiotepa (10 mg/ml) 58.8 minutes.

Source page: https://510kreport.com/device/K171873
Methodology: https://510kreport.com/methodology