# K030994: Non-Sterile Orange Colored Powdered Latex Patinet Examination Gloves with & Without Orange/Vanilla Scents

- Pathway: 510(k) (Traditional)
- Applicant: Sgmp Co., Ltd.
- Decided: Jun 12, 2003 after 76 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)

## Indications for use
A patient examination glove 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/K030994
Methodology: https://510kreport.com/methodology