# K984395: Surgeon's Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Sri Anusham Rubber Industries Pvt., Ltd.
- Decided: May 21, 1999 after 164 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.
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 its predicate without a number.
- (no number) Class 1 - Surgeon’s Gloves (Pre-Powdered): named in the summary without a submission number

## Indications for use
Surgeon's Glove is a medical device intended to be worn by operating room personnel during surgery to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K984395
Methodology: https://510kreport.com/methodology