# K143419: Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Mar 6, 2015 after 98 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Latex Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove - Lemon Green is a non — sterile disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K143419
Methodology: https://510kreport.com/methodology