# K212834: Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Siyang Threeguard Medical Supplies Co., Ltd.
- Decided: Dec 30, 2021 after 114 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: 6 generations back to K042805 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201390: Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs), Medline Industires, Inc. (2020) Summary page 6.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Carmustine (BCNU) Cisplatin Cyclophosphamide (Cytoxan) Dacarbazine Doxorubicin HCI Etoposide Fluorouracil Methotrexate Miromycin C Paclitaxel ThioTepa Vincristine Sulface Concentration Breakthrough Detection Time in Minutes 3.3 mg/ml (3,300 ppm) 1.0 mg/ml(1,000 ppm) 20.0 mg/ml(20,000 ppm) 10.0 mg/ml(10,000 ppm) 2.0 mg/ml(2,000 ppm) 20.0 mg/ml(20,000 ppm) 50.0 mg/ml1(50,000 ppm) 25.0 mg/ml(25,000 ppm) 0.5 mg/ml(500 ppm) 6.0 mg/ml(6,000 ppm) 10.0 mg/ml(10,000 ppm) 1.0 mg/ml(1,000 ppm) Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 15.2 Minutes Thio-Tepa 10.0 mg/ml 45.8 Minutes Warning: Please do not use with Carmustine 15.2 Minutes > 240 Minutes > 240 Minutes > 240 Minutes > 240 Minutes > 240 Minutes > 240 Minutes > 240 Minutes > 240 Minutes > 240 Minutes 45.8 Minutes > 240 Minutes

Source page: https://510kreport.com/device/K212834
Methodology: https://510kreport.com/methodology