# K000868: Non-Sterile Powder-Free, Blue Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Sgmp Co., Ltd.
- Decided: Apr 20, 2000 after 34 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K072400: Non-Sterile, Powder-Free, Black Nitrile Examination Gloves (2008), 1 descendant of its own
- K101646: Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor (2010), 0 descendants of its own
- K062138: Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free Polychloroprene Sterile Examination Glove (2006), 0 descendants of its own
- K042879: Non-Sterile Powder-Free Blue Nitrile Examination Gloves, with Vanilla Scenting (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K000868
Methodology: https://510kreport.com/methodology