# K993876: Powder-Free Nitrile Examination Gloves with Aloe Vera

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei (Usa), Inc.
- Decided: Feb 7, 2000 after 84 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162312: Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color (2017), 1 descendant of its own
- 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
Powder-Free Nitrile Exam Glove with Aloe Vera 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 not intended to be used as a chemical barrier.

Source page: https://510kreport.com/device/K993876
Methodology: https://510kreport.com/methodology