# K051333: Nitrile Examination Gloves, Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Shun Thai Rubber Gloves Industry Co., Ltd.
- Decided: Jul 22, 2005 after 60 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K102846: Patient Examination Gloves (2011), 0 descendants of its own
- K092617: Royal Guard (2010), 0 descendants of its own

## Indications for use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K051333
Methodology: https://510kreport.com/methodology