# K223415: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Mah Sing Healthcare Sdn. Bhd.
- Decided: Jan 26, 2023 after 77 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)
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Comfort Rubber Gloves Industries Sdn. Bhd. (2020) Summary page 6.

## Indications for use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drugs are as follows: Test Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes *Carmustine | 3.3mg/ml | 14.1 Cisplatinl mg/ml | >240 Cyclophosphamide | 20 mg/ml | >240 Dacarbazine | 10 mg/ml | >240 Doxorubicin, HCI2 mg/ml | >240 Etoposide20 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 | 57.2 Vincristine | 1 mg/ml | >240 Test Fentanyl Citrate are as follows: Test Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes Fentanyl Citrate Injection | 100mcg/2ml | >240 Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: (1)Carmustine — 14.1 minutes (2)Thiotepa — 57.2 minutes.

Source page: https://510kreport.com/device/K223415
Methodology: https://510kreport.com/methodology