# K991849: Non-Sterile Powder-Free Latex Examination Gloves with a Protein Labeling Claim (50 Micrograms or Less Total Water Extrac

- Pathway: 510(k) (Traditional)
- Applicant: Seal Polymer Industries Bhd.
- Decided: Jul 7, 1999 after 36 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
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 patients’ body, fluids, waste or environment.

Source page: https://510kreport.com/device/K991849
Methodology: https://510kreport.com/methodology