# K162312: Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei USA, Inc.
- Decided: Jul 25, 2017 after 341 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: 1 generation back to K993876 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993876: Powder-Free Nitrile Examination Gloves with Aloe Vera, Shen Wei (Usa), Inc. (2000) Summary page 5.

## Most influential descendants
- K221983: Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color (2023), 0 descendants of its own

## Indications for use
The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green 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/K162312
Methodology: https://510kreport.com/methodology