# K072403: Non-Sterile, Powdered, Pink Latex Examination Gloves with Cherry Flavour and Protein Labeling Claims (200 UG or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Sgmp Co., Ltd.
- Decided: Mar 27, 2008 after 213 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 K000671 (2000). 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)
- K000671: Powdered Latex Exam Gloves, Pink, with/Without Strawberry Scent, Protein Labeling, Sgmp Co., Ltd. (2000) Summary page 1.

## Indications for use
The Non-Sterile Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 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/K072403
Methodology: https://510kreport.com/methodology