# K081569: Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: Dynarex Corporation
- Decided: Sep 12, 2008 after 100 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: 2 generations back to K013016 (2001). 2 ancestors in all.
1 later device descends 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)
- K042378: Non-Sterile Powder Free Blue Nitrile Patient Examination Glove, Shijiazhuang Tillotson Rubber Products Co., Ltd. (2004) Summary page 1.
- (no number) Medline Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs): named in the summary without a submission number

## Most influential descendants
- 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 purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. These gloves are tested for use with Chemotherapy Drugs.

Source page: https://510kreport.com/device/K081569
Methodology: https://510kreport.com/methodology