# K952050: Glove, Examination, Vinyl

- Pathway: 510(k) (Traditional)
- Applicant: Oak Carolina, Inc.
- Decided: Aug 12, 1996 after 469 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.
No later device cites it as a predicate yet.
0 of 1 device 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) other vinyl examination gloves: named in the summary without a submission number

## Indications for use
Their intended use is to prevent an interchange of body fluids via the hands of the wearer and the person (patient) being examined. Specifically, they are designed to prevent blood or other body fluids from the hands of the wearer from being transferred to the examinee. Also they are designed to prevent body fluids from the examinee from being transferred to the wearer via the wearer’s hands.

Source page: https://510kreport.com/device/K952050
Methodology: https://510kreport.com/methodology