# K982720: H-RAY

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Hongray Plastic Products Co., Ltd.
- Decided: Nov 5, 1998 after 93 days
- Product code: LYZ (Vinyl 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 no predicate by number.

## Indications for use
This glove is to be worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Source page: https://510kreport.com/device/K982720
Methodology: https://510kreport.com/methodology