# K180646: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: Halyard Health
- Decided: Jun 27, 2018 after 107 days
- Product code: LZC (Medical Glove, Specialty)
- 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: 5 generations back to K042805 (2004). 6 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172525: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, Central Medicare Sdn Bhd (2017) Summary page 4.

## Most influential descendants
- K191230: Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves (2019), 3 descendants of its own
- K202622: Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate (2021), 2 descendants of its own
- K231938: Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (2024), 1 descendant of its own
- K182851: SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (2019), 1 descendant of its own
- K243133: Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (2025), 0 descendants of its own

## Indications for use
The Halyard Lavender 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: 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 0.3 minutes ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes Warning: Not for Use With : Carmustine, ThioTEPA

Source page: https://510kreport.com/device/K180646
Methodology: https://510kreport.com/methodology