# K220609: Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)

- Pathway: 510(k) (Traditional)
- Applicant: Encompass Industries Sdn. Bhd.
- Decided: May 27, 2022 after 86 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 K183287 (2019). 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)
- K200181: Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Comfort Rubber Gloves Industries Sdn. Bhd. (2020) Summary page 5.

## Indications for use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation. The following chemotherapy drugs have been tested with the glove: Chemotherapy Drugs Carmustine Cisplatin Cyclophosphamide Dacarbazine Doxorubicin HCL Etoposide Fluorouracil Methotrexate Paclitaxel ThioTepa Mitomycin C Vincristine Sulfate Fentanyl Citrate Concentration 3.3 mg/ml 1.0 mg/ml 20.0 mg/ml 10.0 mg/ml 2.0 mg/ml 20.0 mg/ml 50.0 mg/ml 25.0 mg/ml 6.0 mg/ml 10.0 mg/ml 0.5 mg/ml 1.0 mg/ml 100 mcg/2mL Breakthrough Detection Time in Minutes White 11.2 >240 >240 >240 >240 >240 >240 >240 >240 25.2 >240 >240 >240 Blue 10.7 >240 >240 >240 >240 >240 >240 >240 >240 21.5 >240 >240 >240 *Please note that the following 2 drugs have extremely low permeation times: 1. Carmustine 2. Thiotepa Warning: Do not use with Carmustine and ThioTepa. Black 11.0 >240 >240 >240 >240 >240 >240 >240 >240 11.1 >240 >240 >240 Orange 67.3 >240 >240 >240 >240 >240 >240 >240 >240 47.8 >240 >240 >240 Green 67.1 >240 >240 >240 >240 >240 >240 >240 >240 169.1 >240 >240 >240

Source page: https://510kreport.com/device/K220609
Methodology: https://510kreport.com/methodology