# K982416: Shun-Thai - Safe-Contact, Boston Medical Latex Exam Glove, Shun-Thai Latex Exmination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Shun Thai Rubber Gloves Industry Co., Ltd.
- Decided: Nov 24, 1998 after 134 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
“A medical glove is worn on the hand(s) of health care and similar personnel To prevent contamination between heatlh care personnel and the patient.”

Source page: https://510kreport.com/device/K982416
Methodology: https://510kreport.com/methodology