# K250069: Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

- Pathway: 510(k) (Traditional)
- Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
- Decided: Apr 29, 2025 after 109 days
- Product code: LYY (Latex 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 K141042 (2015). 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)
- K192329: Blue Latex Examination Powder Free Gloves, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2019) Summary page 5.

## Indications for use
Powder Free Natural Rubber Latex Examination Gloves — Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm?2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between examiner and patient.

Source page: https://510kreport.com/device/K250069
Methodology: https://510kreport.com/methodology