# K243694: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue

- Pathway: 510(k) (Traditional)
- Applicant: Mah Sing Healthcare Sdn. Bhd.
- Decided: Jun 6, 2025 after 189 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: 3 generations back to K082457 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240080: Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Syntex Healthcare Products Co., Ltd. (2024) Summary page 6.

## Indications for use
A 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Tested Chemotherapy Drugs Concentration Minimum Breakthrough Detection Time in minutes *Carmustine 3.3mg/ml 22.5 Cisplatin 1 mg/ml >240 Cyclophosphamide 20 mg/ml >240 Dacarbazine 10 mg/ml >240 Doxorubicin, HCl 2 mg/ml >240 Etoposide 20 mg/ml >240 Fluorouracil 50 mg/ml >240 Methotrexate 25 mg/ml >240 Mitomycin 0.5 mg/ml >240 Oxaliplatin 5 mg/ml >240 Paclitaxel 6 mg/ml >240 *Thiotepa 10 mg/ml 34.5 Vincristine 1 mg/ml >240 Tested Opioid Drugs Concentration Minimum Breakthrough Detection Time in minutes Fentanyl Citrate Injection 100mcg/2ml >240 Warning: Do not use with Carmustine and Thiotepa. *Note: Please note that the following drugs have low permeation times: (1) Carmustine – 22.5 minutes (2) Thiotepa – 34.5 minutes.

Source page: https://510kreport.com/device/K243694
Methodology: https://510kreport.com/methodology