# K032294: Non-Sterile, Powder Free Orange Latex Examination Gloves W/ or Without Orange/Vanilla Scenting Plus a Protein Labeling

- Pathway: 510(k) (Traditional)
- Applicant: Sgmp Co., Ltd.
- Decided: Aug 28, 2003 after 34 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 K011370 (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)
- K011370: Non-Sterile Powder Free Purple Latex Examination Glove with and Without Grape Scent and with Protein Labeling (50 Microg, Sgmp Co., Ltd. (2001)

## Indications for use
This is a medical glove to be worn on the hand of health care and similar personnel to prevent Contamination between health care personnel and the patient.

Source page: https://510kreport.com/device/K032294
Methodology: https://510kreport.com/methodology