# K902633: Cut Resistant Glove Liner

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 27, 1990 after 43 days
- Product code: LYU (Accessory, Surgical Apparel)
- Device class: 1
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 11, 2017 · Class II · Z-0609-2018: Cut resistant surgical glove liners lack sterility assurance.

Source page: https://510kreport.com/device/K902633
Methodology: https://510kreport.com/methodology