# K013016: True Advantage Non-Sterile Powder Free Purple Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Tillotson Healthcare Corp.
- Decided: Oct 19, 2001 after 42 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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) Pilgram Nitrile Latex, Non-Sterile Examination Glove: named in the summary without a submission number

## Most influential descendants
- K042378: Non-Sterile Powder Free Blue Nitrile Patient Examination Glove (2004), 2 descendants of its own
- K081569: Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with Chemotherapy Drugs (2008), 1 descendant of its own
- K111464: Palm-Pro Powder Free Nitrile Examination Gloves (2012), 0 descendants of its own

## Indications for use
The True Advantage Non-Sterile Powder Free Purple Nitrile Patient Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

Source page: https://510kreport.com/device/K013016
Methodology: https://510kreport.com/methodology