# K150612: Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free)

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Anyu Latex Products Co., Ltd.
- Decided: Nov 16, 2015 after 251 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: 2 generations back to K060858 (2006). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072145: Medical Glove Series, Zhanjiang Jiali Glove Products Co., Ltd. (2008) Summary page 5.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K150612
Methodology: https://510kreport.com/methodology