# K160709: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: Halyard Health
- Decided: Sep 6, 2016 after 176 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: 4 generations back to K051347 (2005). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113423: Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove, Kimberly-Clark Corp. (2012) Summary page 4.

## Most influential descendants
- K243604: Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid (2025), 0 descendants of its own
- K182096: Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs (2018), 0 descendants of its own

## Indications for use
HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves tested for Use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE - XTRA* Powder Pree Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes

Source page: https://510kreport.com/device/K160709
Methodology: https://510kreport.com/methodology