# K110979: Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile,Tested for Use W/ Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Products Sdn Bhd
- Decided: Oct 20, 2011 after 196 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K022904 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022904: Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile Examination Gloves, Non-Sterile, Wrp Asia Pacific Sdn. Bhd. (2002) Summary page 1.

## Most influential descendants
- K132354: Powder Free Blude Nitrile Patient Examination Glove, Non-Sterile (2014), 0 descendants of its own

## Recalls of this device
- Aug 25, 2015 · Class II · Z-0133-2016: Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm fai

## Indications for use
The powder free examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment.

Source page: https://510kreport.com/device/K110979
Methodology: https://510kreport.com/methodology