# K102096: Powder Free Nitrile Examination Gloves, Blue

- Pathway: 510(k) (Traditional)
- Applicant: Syntex Healthcare Products Co., Ltd.
- Decided: Oct 4, 2010 after 69 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 K093726 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093726: Mediguard Nitrile Examination Glove- Blue (Tested for Use with Chemotherapy Drugs), Medline Industries, Inc. (2010) Summary page 1.

## Most influential descendants
- K140816: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (2014), 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 finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection times are as follows: Chemotherapy Drug Average BDT Fluorouracil >240 min. Etoposide (Toposar) >240 min., Cyclophosphamide (Cytoxan) >240 min. Carmustine 2.03 min. Thiotepa 25.23 min. Paclitaxel (Taxol) >240 min. Doxorubicin Hydrochloride >240 min. Dacarbazine (DTIC) >240 min. Cisplatin >240 min. Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes.

Source page: https://510kreport.com/device/K102096
Methodology: https://510kreport.com/methodology