# K993326: Non-Sterile Polymer Coated Powder Free Latex Examination Gloves with a Protein Labeling Claim (70 Micrograms or Less Per

- Pathway: 510(k) (Traditional)
- Applicant: Seal Polymer Industries Bhd.
- Decided: Nov 17, 1999 after 44 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 Polymer Coated 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 patients’ body, fluids, waste or environment.

Source page: https://510kreport.com/device/K993326
Methodology: https://510kreport.com/methodology