# K213051: Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Yunnan Huazhiyuan Medical Technology Co., Ltd.
- Decided: Dec 18, 2021 after 87 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 K182176 (2019). 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)
- K190860: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color, Ever Growth (Vietnam) Co., Ltd. (2019) Summary page 4.

## Indications for use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner’s hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Carboplatin 10.0 mg/ml(10,000 ppm) > 240 Minutes Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 35.2 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml(20,000 ppm) > 240 Minutes Doxorubicin 2.0 mg/ml(2,000 ppm) > 240 Minutes Etoposide 20.0 mg/ml(20,000 ppm) > 240 Minutes Fluorouracil 50.0 mg/ml(50,000 ppm) > 240 Minutes Methotrexate 25.0 mg/ml(25,000 ppm) > 240 Minutes Paclitaxel 6.0 mg/ml(6,000 ppm) > 240 Minutes ThioTepa 10.0 mg/ml(10,000 ppm) 76.3 Minutes Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.2 Minutes ThioTepa 10.0 mg/ml 76.3 Minutes Warning: Please do not use with Carmustine (BCNU) and ThioTepa.

Source page: https://510kreport.com/device/K213051
Methodology: https://510kreport.com/methodology