# K202082: Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei USA, Inc.
- Decided: Mar 17, 2021 after 233 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
A patient 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. These gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate and Simulated Gastric Acid.

Source page: https://510kreport.com/device/K202082
Methodology: https://510kreport.com/methodology