# K223748: Nitrile Exam Gloves (Chemotherapy Drug Tested)

- Pathway: 510(k) (Traditional)
- Applicant: Us Medical Glove Company, LLC
- Decided: Jan 13, 2023 after 30 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A powder-free, nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand 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: Drug Name | Concentration Tested | Minimum Breakthrough Detection Time (Minutes) Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 Fluorouracil | 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | No breakthrough up to 240 Cisplatin | 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | No breakthrough up to 240 lfosfamide | 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 Mitoxantrone | 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | No breakthrough up to 14.3 * Thiotepa | 10.0 mg/ml (10,000 ppm) | No breakthrough up to 48.2 * *Please note that Carmustine and Thiotepa have low permeation times. Warning: Do not use with Carmustine and/or Thiotepa.

Source page: https://510kreport.com/device/K223748
Methodology: https://510kreport.com/methodology