# K004018: Skingard Polycoat Glove

- Pathway: 510(k) (Traditional)
- Applicant: Top Quality Mfg., Inc.
- Decided: May 11, 2001 after 135 days
- Product code: LYY (Latex 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013254: Polycoat Powdered Latex Examination Glove with Aloe Vera & Protein Content Labeling Claim (200 Micrograms or Less) (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K004018
Methodology: https://510kreport.com/methodology