# K103675: Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Chienmax Vietnam Co., Ltd.
- Decided: Oct 3, 2011 after 291 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: 4 generations back to K022765 (2002). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101870: Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove, Sunmax Vietnam Co., Ltd. (2010). Cleared while this submission was under review Summary page 1.
- K090828: Non-Sterile, Powder Free Nitrile Examination Gloves, Ultrawin Sdn Bhd (2009) Summary page 2.
- K090464: Black Nitrile Examination Gloves, Powder Free, Non Sterile, Pt Mahakarya Inti Buana (2009) Summary page 2.

## Indications for use
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K103675
Methodology: https://510kreport.com/methodology