# K052877: Powder Free Nitrile Blue Textured Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Syntex Healthcare Products Co., Ltd.
- Decided: Nov 8, 2005 after 27 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 K001128 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001128: Nitrile Exam Gloves, Powder-Free, Color Blue, Shanghai Poseidon Plastic Products Co., Ltd. (2000)

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

Source page: https://510kreport.com/device/K052877
Methodology: https://510kreport.com/methodology