# K082957: Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer Coated, Tested with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: Siam Sempermed Corp., Ltd.
- Decided: May 29, 2009 after 238 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K101822: Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2010), 5 descendants of its own
- K111248: Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) (2011), 4 descendants of its own
- K211810: Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) (2022), 1 descendant of its own
- K193666: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff (2020), 1 descendant of its own
- K243796: GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] (2025), 0 descendants of its own

## Indications for use
Based upon 21 CFR Part 880.6250; "Patient examination glove" A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K082957
Methodology: https://510kreport.com/methodology