# K220249: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Grand Work Plastic Products Co., Ltd.
- Decided: May 26, 2022 after 115 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: 1 generation back to K201531 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201531: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue), Hartalega Sdn Bhd (2020) Summary page 5.

## Indications for use
Glove 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 standards. Gloves is direct contact and not to be worn for more than 24 hours * Please note that the following drugs have extremely low permeation times: Carmustine: 22.4 minutes, Thiotepa: 46.3 minutes WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA Fentanyl Citrate Injection (100 mcg/2ml) >240

Source page: https://510kreport.com/device/K220249
Methodology: https://510kreport.com/methodology