# K082598: Powder Free Blue Patient Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Tangshan Zhonghong Pulin Group Co., Ltd.
- Decided: Jan 7, 2009 after 121 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 K993247 (1999). 1 ancestor in all.
26 later devices descend from it; 6 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993247: Nitrile Powder Free Patient Examination Gloves, Jda Intl., Inc. (1999) Summary page 1.

## Most influential descendants
- K121992: Powder-Free Nitrile Patient Examination Gloves, Blue Color (2012), 16 descendants of its own
- K131440: Powder Free Nitrile Patient Examination Gloves, Blue (2013), 15 descendants of its own
- K150340: POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) (2015), 13 descendants of its own
- K110248: Powder Free Nitrile Patient Examination Gloves, White Color (2011), 4 descendants of its own
- K171615: Xingyu Nitrile Powder Free Patient Examination Gloves, White color (2017), 3 descendants of its own

## Indications for use
Powder Free Blue Patient Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K082598
Methodology: https://510kreport.com/methodology