LYY

Latex Patient Examination Glove

Product code
LYY
Device name
Latex Patient Examination Glove
Device class
Class 1
21 CFR
21 CFR 880.6250
Medical specialty
General Hospital
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1954 (all years; only the last 3 years are listed here)

FDA classification definition

A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-04-29.

NumberDecision dateApplicantDevice nameSummary
K2500692025-04-29Comfort Rubber Gloves Industries Sdn. …Powder Free Natural Rubber Latex Examination Gloves …PDF
K2402662024-09-09Sri Trang Gloves (Thailand) Public Com…Latex Examination Glove Powder Free (Ocean Blue and …

1 summaries are archived here for direct download.

Official FDA classification page: LYY
Classification and pathway per current FDA publications. Data from openFDA (CC0).