# K230002: Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Mah Sing Healthcare Sdn. Bhd.
- Decided: Mar 24, 2023 after 80 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: 5 generations back to K042805 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214110: Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs, Mah Sing Healthcare Sdn. Bhd. (2022) Summary page 4.

## 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 322 Cisplatin 1mg/ml >240 Cyclophosphamide 20mg/ml >240 Dacarbazine 10mg/ml >240 Doxorubicin, HCI 2mg/ml >240 Etoposide 20mg/ml >240 Fluorouracil 50mg/ml >240 Methotrexate 25mg/ml >240 Mitomycin 0.5mg/ml >240 Oxaliplatin Smg/ml >240 Paclitaxel 6mg/ml >240 *Thiotepa 10mg/ml 37.4 Vincristine 1mg/ml >240 Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: (1)Carmustine — 32.2 minutes (2)Thiotepa — 37.4 minutes

Source page: https://510kreport.com/device/K230002
Methodology: https://510kreport.com/methodology