# K102838: Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Thai Hua Holding Co., Ltd.
- Decided: Feb 3, 2011 after 127 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
Longest line of descent: 1 generation back to K891300 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891300: Non-Sterile Patient Examination Glove, Shun Thai Rubber Gloves Industry Co., Ltd. (1989) Summary page 1.

## Indications for use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K102838
Methodology: https://510kreport.com/methodology