# K211209: Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Hycare International Co., Ltd.
- Decided: Dec 17, 2021 after 238 days
- Product code: LZA (Polymer 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: 2 generations back to K000391 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120970: Nitrile Powder Free Patient Examination Gloves, Colored (Blue), Tangshan Zhonghong Pulin Plastic Co.,Ltd (2012) Summary page 6.
- K020042: Hycare Latex Examination Glove, Powder Free, Hycare Intl. Co., Ltd. (2002) Summary page 6.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands or finger to prevent contamination between patient and examiner. Model LWH-0201 - Latex examination gloves non-sterile powder-free polymer coated (Ambidextrous) — palm textured — Color: Natural White - Sizes: X-Small, Small, Medium, Large and X-Large A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands or finger to prevent contamination between patient and examiner. Model NBL-0201 - Nitrile examination gloves non-sterile powder-free (Ambidextrous) — Finger textured - Color: Blue - Sizes: Small, Medium, Large, X-Large and XX Large

Source page: https://510kreport.com/device/K211209
Methodology: https://510kreport.com/methodology