# K992730: Hwa (and) Silktex Pre-Powdered Latex Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Hwa Teh Industrial Sdn. Bhd.
- Decided: Sep 14, 1999 after 32 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 glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Source page: https://510kreport.com/device/K992730
Methodology: https://510kreport.com/methodology