# K993450: Latex Surgical Gloves, Pre-Powdered

- Pathway: 510(k) (Traditional)
- Applicant: Fitco Dipped Products Pvt., Ltd.
- Decided: Dec 29, 1999 after 78 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
Longest line of descent: 1 generation back to K904972 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904972: Surgicare Sterile Surgical Gloves, Kanam Latex Industries Pvt., Ltd. (1991) Summary page 1.

## Indications for use
This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination. Surface powder should be removed prior to undertaking operative procedures in order to minimise the risk of adverse tissue reaction. Contents sterile until package is opened or damaged.

Source page: https://510kreport.com/device/K993450
Methodology: https://510kreport.com/methodology