# K983240: Neutralon PF Powder Free Brown Latex Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Div. of Ethicon, Inc.
- Decided: Nov 30, 1998 after 76 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) ULTRALON* Powder Free Latex Surgical Gloves: named in the summary without a submission number
- (no number) NEUTRALON* Brown Latex Surgical Gloves: named in the summary without a submission number

## Indications for use
NEUTRALON* PF* Powder Free Brown Latex Surgical Gloves are intended to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer.

Source page: https://510kreport.com/device/K983240
Methodology: https://510kreport.com/methodology