# K013254: Polycoat Powdered Latex Examination Glove with Aloe Vera & Protein Content Labeling Claim (200 Micrograms or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Top Quality Mfg., Inc.
- Decided: Feb 4, 2002 after 129 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
Longest line of descent: 1 generation back to K004018 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K004018: Skingard Polycoat Glove, Top Quality Mfg., Inc. (2001) Summary page 1.

## Indications for use
The Top Quality Skingard Polycoat Powdered Latex Examination Glove with Aloe Vera is intended for medical purposes to be womn on the examiner’s hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K013254
Methodology: https://510kreport.com/methodology