# K214110: Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Mah Sing Healthcare Sdn. Bhd.
- Decided: Feb 19, 2022 after 52 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 K042805 (2004). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161422: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs, Wrp Asia Pacific Sdn. Bhd. (2016) Summary page 4.

## Most influential descendants
- K230002: Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (2023), 0 descendants of its own

## 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: Chemotherapy Drugs Permeation The following chemicals have been tested with these gloves. Test Chemotherapy Drugs Concentration Breakthrough Detection Time in minutes *Carmustine 3.3mg/ml 24.8 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 C 0.5 mg/ml >240 Oxaliplatin 5 mg/ml >240 Paclitaxel 6 mg/ml >240 *Thiotepa 10 mg/ml 38.4 Vincristine 1 mg/ml >240 Warning- Not for use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K214110
Methodology: https://510kreport.com/methodology