# K212735: Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Xingyu Medical Tech Co., Ltd.
- Decided: Jan 11, 2022 after 134 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 K051378 (2005). 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)
- K200960: Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs), Medline Industires, Inc. (2020) Summary page 6.

## Indications for use
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug — Concentration — Breakthrough time Carmustine (BCNU) — 3.3mg/ml (3,300ppm) — 47.9(68.2,47.9,69.3) Cyclophosphamide (Cytoxan) — 20.Omg/ml (20,000ppm) — >240 min Doxorubicin HCI — 2.0 mg/ml (2,000ppm) — >240 min Etoposide — 20.0 mg/ml (20,000ppm) — >240 min Fluorouracil — 50.0 mg/ml (50,000ppm) — >240 min Paclitaxel — 6.0 mg/ml (6,000ppm) — >240 min ThioTepa — 10.0 mg/ml (10,000ppm) — >240 min Bleomycin Sulfate(Blenoxane) — 15mg/ml (15,000ppm) — >240 min Carboplatin — 10 mg/ml (10,000ppm) — >240 min Cisplatin — 1.0 mg/ml (1,00Oppm) — >240 min Cytarabine — 100mg/ml(100,000ppm) — >240 min Dacarbazine — 10.Omg/ml (10,000ppm) — >240 min Idarubicin HCL — lmg/ml (1,00Oppm) — >240 min Ifosfamide — 50mg/ml (50,00ppm) — >240 min Mechlorethamine HCL — lmg/ml (1,000ppm) — >240 min MESNA — 100mg/ml (100,000ppm) — >240 min Methotrexate — 25mg/ml (25,000ppm) — >240 min Mitomycin C — 0.5 mg/ml (500ppm) — >240 min Mitoxantrone — 2mg/ml( 2,000ppm) — >240 min Trisenox — 1 mg/ml(1,000ppm) — >240 min Vincristine Sulfate — 1 mg/ml (1,000ppm) — >240 min Do Not Use with Carmustine (BCNU).

Source page: https://510kreport.com/device/K212735
Methodology: https://510kreport.com/methodology