# K022530: Powdered Latex Exam Gloves with Protein Labeling (200UG/G or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Hycare Intl. Co., Ltd.
- Decided: Aug 26, 2002 after 26 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 K000390 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001327: Powdered Latex Exam Gloves, Protein Labeling (150 Microgram or Less), Premier Pathway Sdn. Bhd. (2000) Summary page 1.
- K000390: Vital Shield Gold Powdered Latex Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less), Sgmp Co., Ltd. (2000) Summary page 1.

## 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/K022530
Methodology: https://510kreport.com/methodology