# K212036: Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yanfang Medical Technology Co., Ltd.
- Decided: Oct 5, 2021 after 97 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: 7 generations back to K042805 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190736: Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs, Ever Growth (Vietnam) Co., Ltd. (2019) Summary page 5.

## 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) 16.4 Minutes Cisplatin 1.0 mg/ml(1,000 ppm) > 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml(20,000 ppm) > 240 Minutes Dacarbazine 10.0 mg/ml(10,000 ppm) > 240 Minutes Docetaxel 10.0 mg/ml(10,000 ppm) > 240 Minutes Doxorubicin HCI 2.0 mg/ml(2,000 ppm) > 240 Minutes Epirubicin HCI 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 Gemcitabine 38.0 mg/ml(38,000 ppm) > 240 Minutes Ifosfamide 50.0 mg/ml(50,000 ppm) > 240 Minutes Irinotecan 20.0 mg/ml(20,000 ppm) > 240 Minutes Methotrexate 25.0 mg/ml(25,000 ppm) > 240 Minutes Miromycin C 0.5 mg/ml(500 ppm) > 240 Minutes Mitoxantrone 2.0 mg/ml(2,000 ppm) > 240 Minutes Oxaliplatin 5.0 mg/ml(5,000 ppm) > 240 Minutes Paclitaxel 6.0 mg/ml(6,000 ppm) > 240 Minutes ThioTepa 10.0 mg/ml(10,000 ppm) 98.6 Minutes Vincristine Sulface 1.0 mg/ml(1,000 ppm) > 240 Minutes The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 3.3 mg/ml 16.4 Minutes Thio Tepa 10.0 mg/ml 98.6 Minutes Warning: Please do not use with Carmustine (BCNU).

Source page: https://510kreport.com/device/K212036
Methodology: https://510kreport.com/methodology