# K042378: Non-Sterile Powder Free Blue Nitrile Patient Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Tillotson Rubber Products Co., Ltd.
- Decided: Sep 20, 2004 after 19 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
Longest line of descent: 1 generation back to K013016 (2001). 1 ancestor in all.
2 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)
- K013016: True Advantage Non-Sterile Powder Free Purple Nitrile Examination Glove, Tillotson Healthcare Corp. (2001)

## Most influential descendants
- 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
A patient examination glove is disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K042378
Methodology: https://510kreport.com/methodology