# K022091: Baldur Brand Vinyl Powder-Free Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Tangshan Zhonghong Pulin Group Co., Ltd.
- Decided: Dec 30, 2002 after 186 days
- Product code: LYZ (Vinyl 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
No predicates in its family tree.
9 later devices descend from it; 9 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Class I vinyl patient examination gloves, powder-free, that meet all the requirements of ASTM D 5250-00: named in the summary without a submission number

## Most influential descendants
- K191092: Powder-Free Vinyl Patient Examination Gloves, Yellow Color (2019), 0 descendants of its own
- K190095: Powder-Free Clear Vinyl Patient Examination Gloves (2019), 0 descendants of its own
- K171460: Powder-free Clear Vinyl Patient Examination Gloves (2017), 0 descendants of its own
- K161390: Vinyl Exam Gloves, Powder Free, Clear (2016), 0 descendants of its own
- K142892: Powder-free Clear Vinyl Patient Examination Gloves (2015), 0 descendants of its own

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

Source page: https://510kreport.com/device/K022091
Methodology: https://510kreport.com/methodology