# K000421: Biogel Neotech II Powder-Free Neoprene Surgeon's Glove

- Pathway: 510(k) (Traditional)
- Applicant: Ssl Americas, Inc. (Regent Medical)
- Decided: Aug 14, 2000 after 188 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- 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.
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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020308: Regent Biogel Skinsense Sterile Powder-Free, Synthetic Polyisoprene Surgeon's Glove (2002), 0 descendants of its own

## Recalls of this device
- Nov 25, 2002 · Not classified · Z-0346-03: Sulfur particles on the surface of gloves.

Source page: https://510kreport.com/device/K000421
Methodology: https://510kreport.com/methodology