# K220118: Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Kl-Kepong Rubber Products Sdn. Bhd.
- Decided: May 12, 2022 after 118 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: 7 generations back to K042805 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182851: SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs, O&M Halyard, Inc. (2019) Summary page 4.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K220118
Methodology: https://510kreport.com/methodology