# K222892: Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Grand Work Plastic Products Co., Ltd.
- Decided: Dec 15, 2022 after 83 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 K203036 (2021). 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)
- K203036: Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors), Central Medicare Sdn Bhd (2021) Summary page 4.

## Indications for use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019) Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes Carmustine 3.3 mg/ml (3,300 ppm) 24.0 Cisplatin 1mg/ml (1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 Dacarbazine 10 mg/ml (10,000 ppm) >240 Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 Etoposide, 20 mg/ml (20,000 ppm) >240 Fluorouracil, 50mg/ml (50,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Paclitaxel, 6mg/ml (6,000ppm) >240 Thiotepa, 10mg/ml (10,000ppm) 0.6 * Please note that the following drugs have extremely low permeation times: Carmustine: 24.0 minutes, Thiotepa: 0.6 minutes Warning: Do not use with Carmustine or Thiotepa.

Source page: https://510kreport.com/device/K222892
Methodology: https://510kreport.com/methodology