# K110921: Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Apr 15, 2011 after 14 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: 1 generation back to K022765 (2002). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022765: Nitrile Powder-Free Examination Gloves, Allegiance Healthcare Corp. (2002) Summary page 2.

## Most influential descendants
- K141623: Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim (2014), 6 descendants of its own
- K152542: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs (2015), 3 descendants of its own
- K181066: Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims (2018), 1 descendant of its own
- K233560: Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid (2024), 0 descendants of its own
- K193121: GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (2020), 0 descendants of its own

## Indications for use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug and Concentration — Minimum Breakthrough Detection Time in Minutes, 0.01 jgg/cm2/minute 1. Carmustine (BCNU) (3.3 mg/mI) — 0.61 2. Cisplastm, (1.0mg/mi) — >240 3. Cyclophosphamide (20 mg/mI) — >240 4. -Doxorubicin HCI (2.0 mg/mI) — >240 5. Etoposide (Toposar) (20 mg/mI) — >240 6. 5-Fluorouracil (50 mg/mI) — >240 7. Methotrexate (25 mg/nil) .>240 8. Paclitaxel (Taxol) (6.0 mg/mI) — >240 9. 1Thiotepa (10 mg/mI) — 10.6 The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/mI) Thiotepa (10 mg/mI)

Source page: https://510kreport.com/device/K110921
Methodology: https://510kreport.com/methodology