# K014055: Non-Sterile Powdered Latex Examination Gloves with a Protein Claim on Labeling

- Pathway: 510(k) (Traditional)
- Applicant: Seal Polymer Industries Bhd.
- Decided: Jan 28, 2002 after 49 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 Powdered Latex Patient Examination Glove 30 LYY: named in the summary without a submission number

## Indications for use
This is a medical glove to bs worn on the hand of health carc and similar parsonnel to prevent contamination between health care porsonnel and the patients’ body, fluids, waste

Source page: https://510kreport.com/device/K014055
Methodology: https://510kreport.com/methodology