# K072406: Non-Sterile, Powder Free, Pink Latex Examination Gloves with Cherry Flavour and Protein Labeling Claims (50 UG or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Sgmp Co., Ltd.
- Decided: Mar 21, 2008 after 207 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 K011371 (2001). 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)
- K011371: Non-Sterile Powder Free Pink Latex Examination Glove and Non-Sterile Powder Free Pink Latex Examination Glove with Straw, Sgmp Co., Ltd. (2001) Summary page 1.

## Indications for use
The Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (50 Micrograms or less) is a 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/K072406
Methodology: https://510kreport.com/methodology
