# K000323: Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Siam Sempermed Corp., Ltd.
- Decided: Apr 5, 2000 after 63 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.
101 later devices descend from it; 1 cites it directly.
0 of 102 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
- K060753: Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating, Model Blue:  All Sizes (XS-XL) (2006), 100 descendants of its own
- K080520: Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with Chemotherapy Claim (2008), 97 descendants of its own
- K090420: Smith & Nephew Pigalileo Screw Targeting System V 1.0 (2009), 78 descendants of its own
- K092497: Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 (2009), 77 descendants of its own
- K100107: Smith & Nephew Sureshot Distal Targeting System V2.0 (2010), 75 descendants of its own

Source page: https://510kreport.com/device/K000323
Methodology: https://510kreport.com/methodology