# K071072: Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai China Star Corp
- Decided: Aug 30, 2007 after 136 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 K022765 (2002). 2 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K040841: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs), Medline Industries, Inc. (2004) Summary page 2.
- K022765: Nitrile Powder-Free Examination Gloves, Allegiance Healthcare Corp. (2002) Summary page 2.

## Most influential descendants
- K090336: Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs (2009), 5 descendants of its own
- 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

## 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. These gloves are not intended to be used as a chemical barrier

Source page: https://510kreport.com/device/K071072
Methodology: https://510kreport.com/methodology