# K241528: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential

- Pathway: 510(k) (Traditional)
- Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
- Decided: Aug 6, 2024 after 68 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: 1 generation back to K162646 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162646: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue), Hartalega NGC Sdn. Bhd. (2017) Summary page 6.

## Indications for use
The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner’'s hand or finger to prevent contamination between examiner and patient.

Source page: https://510kreport.com/device/K241528
Methodology: https://510kreport.com/methodology