# K984558: Derma Prene Powder-Free Synthetic Surgical Gloves (Chemotherapy Use)

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Perry
- Decided: Feb 26, 1999 after 65 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: 9 (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. The FDA summary names no predicate by number.

## Recalls of this device
- Oct 24, 2016 · Class II · Z-0893-2017: Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex s
- May 19, 2009 · Not classified · Z-0413-2010: Surgical gloves in hospital convenience kits may be degraded and tear during use.
- May 1, 2009 · Not classified · Z-1586-2009: Premature degradation which could result in tearing during use.
- May 1, 2009 · Not classified · Z-1587-2009: Premature degradation which could result in tearing during use.
- May 1, 2009 · Not classified · Z-1588-2009: Premature degradation which could result in tearing during use.
- May 1, 2009 · Not classified · Z-1583-2009: Premature degradation which could result in tearing during use.
- May 1, 2009 · Not classified · Z-1589-2009: Premature degradation which could result in tearing during use.
- May 1, 2009 · Not classified · Z-1585-2009: Premature degradation which could result in tearing during use.
- May 1, 2009 · Not classified · Z-1584-2009: Premature degradation which could result in tearing during use.

## Indications for use
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.

Source page: https://510kreport.com/device/K984558
Methodology: https://510kreport.com/methodology