# K072400: Non-Sterile, Powder-Free, Black Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Sgmp Co., Ltd.
- Decided: Mar 27, 2008 after 213 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 K000868 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K000868: Non-Sterile Powder-Free, Blue Nitrile Examination Gloves, Sgmp Co., Ltd. (2000) Summary page 1.

## Most influential descendants
- K101646: Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor (2010), 0 descendants of its own

## Indications for use
The Non-sterile Powder Free Black 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/K072400
Methodology: https://510kreport.com/methodology