# K213306: Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Zibo Sinocare Plastic Products Co., Ltd.
- Decided: Feb 18, 2022 after 137 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)
- K211714: Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy), Hengchang (Dongying) Medical Technology Co., Ltd. (2021) Summary page 4.

## 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) 16.9 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 HCI 2.0 mg/ml(2,000 ppm) >240 Eotoside (Toposar) 20.0 mg/ml(20,000 ppm) >240 Fluorouracil 50.0 mg/ml(50,000 ppm) >240 Mechlorethamine 1.0 mg/ml(1,000 ppm) >240 Methotrexate 25.0 mg/ml(25,000 ppm) >240 Mitomycin C 0.5 mg/ml(500 ppm) >240 Paclitaxel (Taxol) 6.0 mg/ml(6,000 ppm) >240 Thio Tepa 10.0 mg/ml(10,000 ppm) 22.6 Vincristine Sulfate 1.0 mg/ml(1,000 ppm) >240 Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3mg/mi 16.9 Minutes Thio Tepa 10.0 mg/mi 22.6 Minutes. Warning: Don't to use with either Carmustine or Thio Tepa

Source page: https://510kreport.com/device/K213306
Methodology: https://510kreport.com/methodology