# K132354: Powder Free Blude Nitrile Patient Examination Glove, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Health Products, Lot 60 & 61
- Decided: Jun 30, 2014 after 336 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: 2 generations back to K022904 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110979: Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile,Tested for Use W/ Chemotherapy Drugs, Advanced Medical Products Sdn Bhd (2011) Summary page 1.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examinees hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K132354
Methodology: https://510kreport.com/methodology