# K972009: Pure Advantage Nitrile Hypoallergenic Surgical Glove

- Pathway: 510(k) (Traditional)
- Applicant: Tillotson Healthcare Corp.
- Decided: Sep 12, 1997 after 105 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K815086: Pure Advantage Nitrile Surgical Glove. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The Pure Advantage Nitrile Surgical Glove, Hypoallergenic is “a disposable device intended for medical purposes that is wormn by operating room personnel to protect a surgical wound from contamination" (21CFR 878.4460).

Source page: https://510kreport.com/device/K972009
Methodology: https://510kreport.com/methodology