# K090336: Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Sunmax Enterprise Shanghai Co., Ltd.
- Decided: Jul 1, 2009 after 141 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 K022765 (2002). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071072: Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove, Shanghai China Star Corp (2007) Summary page 2.
- K040841: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs), Medline Industries, Inc. (2004) Summary page 2.

## Most influential descendants
- K102593: Synthetic, Powder-Free Nitrile Examination (2010), 1 descendant of its own
- K101870: Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove (2010), 1 descendant of its own
- K211667: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) (2021), 0 descendants of its own
- K103675: Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination Glove (2011), 0 descendants of its own
- K101943: Synthetic, Powder-Free Nitrile Examination Gloves (2010), 0 descendants of its own

## Indications for use
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. Chemotherapy drugs with their breakthrough times: Dacarbazine 240 minutes Cyclophosphamide(Cytoxan) 240 minutes Doxorubicin Hydrochloride 240 minutes Fluorouracil 240 minutes Cisplatin 240 minutes Etoposide (Toposar) 240 minutes Paclitaxel (Taxol) 240 minutes Thio-Tepa 23.3 minutes Carmustine 18.7 minutes

Source page: https://510kreport.com/device/K090336
Methodology: https://510kreport.com/methodology