# K213227: Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Uweport, LLC
- Decided: Jan 19, 2022 after 112 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: 8 generations back to K042805 (2004). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210944: Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue), Harbour Health, LLC (2021) Summary page 4.

## Most influential descendants
- K221350: Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) (2022), 0 descendants of its own

## Indications for use
Uweport 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. Warning: Not recommended for use with Carmustine and Thiotepa. The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times: Camustine (BCNL) 3.3 mg/ml (3,000 ppm) 22.8 minutes Thiotepa 10.0 mg/ml (10,000 ppm) 46.8 minutes

Source page: https://510kreport.com/device/K213227
Methodology: https://510kreport.com/methodology