# K100211: Pearlscent Black Textured Powder-Free Latex Examination Gloves, Coated with Aloe Vera

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei (Usa), Inc.
- Decided: May 11, 2010 after 106 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
Longest line of descent: 1 generation back to K013793 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013793: Powder Free Latex Examination Gloves with Aloe Vera @PH 5.5 and Protein Labeling Claims, Shen Wei (Usa), Inc. (2002) Summary page 1.

## Indications for use
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/K100211
Methodology: https://510kreport.com/methodology