# K001128: Nitrile Exam Gloves, Powder-Free, Color Blue

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Poseidon Plastic Products Co., Ltd.
- Decided: May 23, 2000 after 46 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; 4 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K070862: Powder Free Nitrile Examination Gloves (Blue, Wihte) (2007), 0 descendants of its own
- K060147: Powder Free Nitrile Examination Gloves, Blue (2006), 0 descendants of its own
- K052877: Powder Free Nitrile Blue Textured Examination Glove (2005), 0 descendants of its own
- K014077: Powder Free (Blue) Nitrile Patient Examination Gloves (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K001128
Methodology: https://510kreport.com/methodology