# K221350: Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Rubberex Alliance Products Sdn Bhd
- Decided: Aug 5, 2022 after 87 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: 9 generations back to K042805 (2004). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213227: Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs), Uweport, LLC (2022) Summary page 5.

## Indications for use
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. List of Drugs tested concentration and breakthrough detection time in minutes. The maximum testing time is 240 minutes. Drug Tested — Concentration — Breakthrough Detection Time in Minutes Carmustine (BCNU) — 3.3 mg/mL (3300 ppm) — 14.6 Cisplatin — 1.0 mg/mL (1000 ppm) — > 240 Cyclophosphamide (Cytoxan@) — 20 mg/mL (20000 ppm) — > 240 Dacarbazine (DTCI) — 10 mg/mL (10000 ppm) — > 240 Doxorubicin Hydrochloride — 2.0 mg/mL (2000 ppm) — > 240 Etoposide (Toposar@) — 20 mg/mL (20000 ppm) — > 240 Fluorouracil — 50 mg/mL (50000 ppm) — > 240 Paclitaxel (Taxol@) — 6.0 mg/mL (6000 ppm) — > 240 Thiotepa — 10 mg/mL (10000 ppm) — 15.0 Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: Camustine (BCNU) — 3.3 mg/mL (3300 ppm) — 14.6 minutes Thiotepa — 10.0 mg/mL (10000 ppm) — 15.0 minutes

Source page: https://510kreport.com/device/K221350
Methodology: https://510kreport.com/methodology