# K233560: Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid

- Pathway: 510(k) (Traditional)
- Applicant: Eco Medi Glove Sdn. Bhd.
- Decided: Feb 26, 2024 after 112 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: 5 generations back to K022765 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181066: Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims, Eco Medi Glove Sdn. Bhd. (2018) Summary page 7.

## Indications for use
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a disposable device intended for medical purposes that are worn on the examiner’s hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl, and Gastric Acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Source page: https://510kreport.com/device/K233560
Methodology: https://510kreport.com/methodology