# K030164: Non-Sterile, Powder-Free, Polymer Coated, Natural and/or Violet and Black Color, Latex Examination Gloves with Protein

- Pathway: 510(k) (Traditional)
- Applicant: Yty Industry (Manjung) Sdn Bhd
- Decided: Mar 7, 2003 after 50 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. The FDA summary names its predicate without a number.
- (no number) Class 1 Latex Patient Examination Glove 80 LYY, powder free: named in the summary without a submission number

## 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/K030164
Methodology: https://510kreport.com/methodology