# K992821: Synthetic Powder-Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Hongxiang Plastics Products Co., Ltd.
- Decided: Mar 10, 2000 after 203 days
- Product code: LYZ (Vinyl Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942042 (1994). 2 ancestors in all.
18 later devices descend from it; 18 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964964: Powder-Free Vinyl Patient Examination Gloves, Sunmax Enterprise Shanghai Co., Ltd. (1997) Summary page 1.
- K942042: Powder Free Vinyl Patient Examination Gloves, Cheer & Merit Co., Ltd. (1994) Summary page 1.

## Most influential descendants
- K143340: Powder Free Vinyl Patient Examination Gloves, Yellow Color (2015), 0 descendants of its own
- K140322: White Vinyl Exam Gloves Powder Free (2014), 0 descendants of its own
- K122656: Powder-Free Vinyl Patient Examination Gloves, Yellow Color (2014), 0 descendants of its own
- K132637: Powder-Free Vinyl Patient Examination Gloves, Yellow Color (2014), 0 descendants of its own
- K123590: Vinyl Examination Powder Free Gloves, Clear (2013), 0 descendants of its own

## Recalls of this device
- Apr 30, 2009 · Not classified · Z-1645-2009: The product may contain defects/holes reducing the product's effectiveness as a barrier.

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

Source page: https://510kreport.com/device/K992821
Methodology: https://510kreport.com/methodology