# K223298: Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Intco Medical Products Co, Ltd.
- Decided: Feb 22, 2023 after 118 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 K052728 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171367: SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES), Sanrea Healthcare Products Pvt, Ltd. (2018) Summary page 4.

## Indications for use
The Sterile Latex Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K223298
Methodology: https://510kreport.com/methodology