# K250342: Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: Encompass Industries Sdn. Bhd.
- Decided: Jul 8, 2025 after 152 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: 4 generations back to K082457 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212148: Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs, Ansell Healthcare Products, LLC (2022) Summary page 6.

## Indications for use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on examiner's hand to prevent contamination between patient and examiner. In addition, the glove was evaluated using ASTM D6978 for permeation of chemotherapy drugs and fentanyl citrate. The glove is single use and non-sterile. The following chemotherapy drugs have been tested on the glove: Chemotherapy Drugs Concentration Breakthrough Detection Time Carmustine* 3.3 mg/mL 23.2 min Cisplatin 1.0 mg/mL >240 min Cyclophosphamide 20.0 mg/mL >240 min Dacarbazine 10.0 mg/mL >240 min Doxorubicin HCL 2.0 mg/mL >240 min Etoposide 20.0 mg/mL >240 min Fluorouracil 50.0 mg/mL >240 min Methotrexate 25.0 mg/mL >240 min Paclitaxel 6.0 mg/mL >240 min ThioTepa* 10.0 mg/mL 13.5 min Mitomycin C 0.5 mg/mL >240 min Vincristine Sulfate 1.0 mg/mL >240 min Fentanyl Fentanyl Citrate 100.0 meg/2mL >240 min *Please note that the following drugs have low permeation time. 1. Carmustine 2. ThioTepa Warning: Do not use with Carmustine & ThioTepa

Source page: https://510kreport.com/device/K250342
Methodology: https://510kreport.com/methodology