# K011961: Powder-Free Butadiene Copolymer Exam Gloves with Aloe, Vitamins E PH5.5

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei (Usa), Inc.
- Decided: Sep 26, 2001 after 96 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Powder-Free Butadiene Copolymer Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This product has a pH of 5.5, which is an integral part of this patented product. This is not an antimicrobial/antiseptic glove. This device is not intendeg! to be used as a chemical barrier.

Source page: https://510kreport.com/device/K011961
Methodology: https://510kreport.com/methodology