# K161074: Powder Free Nitrile Examination Gloves Flock-Lined, Black Color

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei (Usa), Inc.
- Decided: Nov 17, 2016 after 213 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: 3 generations back to K000323 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070639: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating, Siam Sempermed Corp., Ltd. (2007) Summary page 4.

## Indications for use
Powder-Free Nitrile Examination Glove Flock-Lined, Black Color is a disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. This device is single use only.

Source page: https://510kreport.com/device/K161074
Methodology: https://510kreport.com/methodology