# K182851: SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: O&M Halyard, Inc.
- Decided: Jun 26, 2019 after 259 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K042805 (2004). 7 ancestors in all.
1 later device descends 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)
- K180646: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs, Halyard Health (2018) Summary page 4.

## Most influential descendants
- K220118: Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves (2022), 0 descendants of its own

## Recalls of this device
- Sep 27, 2021 · Class II · Z-0317-2022: All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.

## Indications for use
The Skybreeze Zero Nitrile Powder-Free Exam 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 the following chemotherapy drugs: Tested Chemotherapy Drugs and Concentration Average Breakthrough Detection Time (Minutes) • Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes • Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes • Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes • 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes • Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes • Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes • Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes • Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes • Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes • Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes • Carmustine (3.3 mg/ml) No breakthrough up to 18.6 minutes • ThioTEPA (10.0 mg.ml) No breakthrough up to 48.3 minutes Warning: Not for Use with: Carmustine, ThioTEPA

Source page: https://510kreport.com/device/K182851
Methodology: https://510kreport.com/methodology