# K214056: Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Mezorrison Medical Technology (Dongying) Co., Ltd.
- Decided: Sep 20, 2022 after 267 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 6.

## 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. 1. The following is the resistance to permeation by chemotherapy drugs for the blue gloves. Chemotherapy Drug Concentration Carboplatin 10.0 mg/ml Carmustine 3.3 mg/ml Cisplatin 1.0 mg/ml Cyclophosphamide 20.0 mg/ml Doxorubicin HCI 2.0 mg/ml Etoposide 20.0 mg/ml Fluorouracil 50.0 mg/ml Paclitaxel 6.0 mg/ml ThioTepa 10.0 mg/ml Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 18.4 Minutes ThioTepa 10.0 mg/ml 26.6 Minutes Etoposide 20.0 mg/ml 202.7 Minutes Warning: Please do not use with Carmustine, ThioTepa and Etoposide. > 240 Minutes 18.4 Minutes > 240 Minutes > 240 Minutes > 240 Minutes 202.7 Minutes > 240 Minutes > 240 Minutes 26.6 Minutes 2. The following is the resistance to permeation by chemotherapy drugs for the purple gloves. Chemotherapy Drug Concentration Carboplatin 10.0 mg/ml Carmustine 3.3 mg/ml Cisplatin 1.0 mg/ml Cyclophosphamide 20.0 mg/ml Doxorubicin HCI 2.0 mg/ml Etoposide 20.0 mg/ml Fluorouracil 50.0 mg/ml Paclitaxel 6.0 mg/ml ThioTepa 10.0 mg/ml Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 20.9 Minutes ThioTepa 10.0 mg/ml 33.5 Minutes Warning: Please do not use with Carmustine and ThioTepa. > 240 Minutes 20.9 Minutes > 240 Minutes > 240 Minutes > 240 Minutes > 240 Minutes > 240 Minutes > 240 Minutes 33.5 Minutes

Source page: https://510kreport.com/device/K214056
Methodology: https://510kreport.com/methodology