# K020042: Hycare Latex Examination Glove, Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Hycare Intl. Co., Ltd.
- Decided: Jul 30, 2002 after 204 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 K000391 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000391: Vital Shield Gold Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less), Sgmp Co., Ltd. (2000)
- K014134: Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G), Supergrade Healthcare Products Sdn. Bhd. (2002). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K211209: Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves (2021), 0 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K020042
Methodology: https://510kreport.com/methodology