# K992200: Textured Powder-Free Latex Examination Gloves with Aloe Vera Green, Contains 50 MCGM or Less of Total Water Extractable

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei (Usa), Inc.
- Decided: Aug 17, 1999 after 48 days
- Product code: LYY (Latex 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Textured Powder-Free Latex Exam Glove with Aloe Vera and Protein Content Labeling Claim, Green 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/K992200
Methodology: https://510kreport.com/methodology