# K962986: Maxxus Powder Free Orthopaedic Latex Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Sep 20, 1996 after 50 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) MAXXUS Orthopaedic Latex Surgical Gloves: named in the summary without a submission number

## Indications for use
MAXXUS Powder Free Orthopaedic 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 sterila fields from microbiological contamination from the wearer.

Source page: https://510kreport.com/device/K962986
Methodology: https://510kreport.com/methodology