# K243796: GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

- Pathway: 510(k) (Traditional)
- Applicant: Glove One, LLC
- Decided: Jun 3, 2025 after 175 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 K082957 (2009). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193666: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff, Medline Industries, Inc. (2020) Summary page 6.

## Indications for use
A patient 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 and fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Tested Breakthrough Time (minutes) Cisplatin 1 mg/ml (1,000 ppm) >240 min Cyclophosphamide 20 mg/m1l (20,000 ppm) >240 min Dacarbazine 10 mg/ml (10,000 ppm) >240 min Doxorubicin HCL 2 mg/ml (2,000 ppm) >240 min Etoposide 20 mg/ml (20,000 ppm) >240 min Fluorouracil 50 mg/ml (50,000 ppm) >240 min Ifosamide 50 mg/ml (50,000 ppm) >240 min Mitroxantrone HCL 2 mg/ml (2,000 ppm) >240 min Paclitaxel 6 mg/ml (16,000 ppm) >240 min Vincristine Sulfate 1 mg/ml (1,000 ppm) >240 min Carmustine 3.3 mg/ml (3,000 ppm) 12.3 minutes Thiotepa 10 mg/ml (10,000 ppm) > 240 min 13.4 minutes Fentanyl Tested Breakthrough Time (minutes) Fentanyl Citrate Injection, 100 mcg/2 mL >240 min WARNING: The following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 12.3 minutes Thiotepa (THT) (10.0 mg/ml) 13.4 minutes

Source page: https://510kreport.com/device/K243796
Methodology: https://510kreport.com/methodology