# K103249: Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Dec 16, 2010 after 43 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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
- K232764: Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2024), 0 descendants of its own
- K122696: Powder-Free Nitrile Examination Gloves (Cool Blue) (2013), 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 Minimum Breakthrough Detection Time Concentration in Minutes, 0.01 pgcmzlminute 1. Carmustine (BCNU) (3.3 mg/ml) 7.28 2. Cisplastin, (1.0mg/ml) >240 3. Cyclophosphamide (20 mg/ml) >240 4. Doxorubicin HCI (2.0 mg/ml) >240 5. Etoposide (Toposar) (20 mg/ml) >240 6. S-Fluorouracil (50 mg/ml) >240 7. Methotrexate (25 mg/ml) >240 8. Paclitaxel (Taxol) (6.0 mg/mi) >240 9. Thiotepa (10 mg/ml) 2.67 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/ml) Thiotepa (10 mg/ml)

Source page: https://510kreport.com/device/K103249
Methodology: https://510kreport.com/methodology