# K043014: Powder Free Natural Rubber Latex Patient Examination Gloves with Labeling Protein Content Claim (50 Micrograms or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Tillotson Rubber Products Co., Ltd.
- Decided: Jan 28, 2005 after 87 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 K021059 (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)
- K021059: Syntex Powder-Free Latex Examination Gloves with Low Protein Claim, Syntex Healthcare Products Co., Ltd. (2002) Summary page 1.

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

Source page: https://510kreport.com/device/K043014
Methodology: https://510kreport.com/methodology