# K994081: Safeskin Tactylon PF Powder-Free Surgeon's Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Safeskin Corp.
- Decided: Jan 18, 2000 after 46 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- 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. The FDA summary names its predicate without a number.
- (no number) Safeskin powdered synthetic surgical glove: named in the summary without a submission number

## Most influential descendants
- K121335: G-Derm Powder-Free Synthetic Surgical Glove (2012), 0 descendants of its own

## Indications for use
A surgeon’s glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.

Source page: https://510kreport.com/device/K994081
Methodology: https://510kreport.com/methodology