# K220228: Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Blue Sail Health Technology Co., Ltd.
- Decided: Mar 18, 2022 after 50 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug — Concentration — Breakthrough Detection Time in Minutes *Carmustine (BCNU) — 3.3 mg/ml (3,300 ppm) — 22.4 Cisplatin — 1.0 mg/ml(l,000 ppm) — >240 Cyclophosphamide (Cytoxan) — 20 mg/ml(20,000 ppm) — >240 Dacarbazine — 10 mg/ml(l 0,000 ppm) — >240 Doxorubicin HCl — 2.0 mg/ml(2,000 ppm) — >240 Etoposide — 20.0 mg/ml(20,000 ppm) — >240 Fluorouracil — 50.0 mg/m1(50,000 ppm) — >240 Methotrexate — 25.0 mg/m1(25,000 ppm) — >240 Mitomycin C — 0.5 mg/m1(500 ppm) — >240 Paclitaxel — 6.0 mg/ml(6,000 ppm) — >240 *Thio Tepa — 10.0 mg/ml(l0,000 ppm) — 73.1 Vincristine Sulfate — 1.0 mg/ml(l ,000 ppm) — >240 Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3mg/ml 22.4 Minutes Thio Tepa 10.0 mg/ml 73.1 Minutes. Warning: Don't use with either Carmustine (BCNU) or Thio Tepa The Powder Free Nitrile Examination Gloves, Violet Blue,Test For Use With Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug — Concentration — Breakthrough Detection Time in Minutes *Carmustine (BCNU) — 3.3 mg/ml (3,300 ppm) — 23.5 Cisplatin — 1.0 mg/ml(1,000 ppm) — >240 Cyclophosphamide (Cytoxan) — 20 mg/ml(20,000 ppm) — >240 Dacarbazine — 10 mg/ml(10,000 ppm) — >240 Doxorubicin HCl — 2.0 mg/ml(2,000 ppm) — >240 Etoposide — 20.0 mg/ml(20,000 ppm) — >240 Fluorouracil — 50.0 mg/ml(50,000 ppm) — >240 Methotrexate — 25.0 mg/ml(25,000 ppm) — >240 Mitomycin C — 0.5 mg/ml(500 ppm) — >240 Paclitaxel — 6.0 mg/ml(6,000 ppm) — >240 *Thio Tepa — 10.0 mg/ml(10,000 ppm) — 66.6 Vincristine Sulfate — 1.0 mg/ml(1,000 ppm) — >240 Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3mg/ml 16.9 Minutes Thio Tepa 23.5 mg/ml 66.6 Minutes. Warning: Don't use with either Carmustine (BCNU) or Thio Tepa

Source page: https://510kreport.com/device/K220228
Methodology: https://510kreport.com/methodology