Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

LYZ

Vinyl Patient Examination Glove

Product code
LYZ
Device name
Vinyl 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)
4
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
799 (all years; only the last 3 years are listed here)

FDA classification definition

A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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 (4)

Last three years. Most recent: 2026-04-07.

NumberDecision dateApplicantDevice nameSummary
K2608602026-04-07Basic Medical Technology, Inc.Powder Free Synthetic Vinyl Exam Gloves (Blue, Black…PDF
K2524672025-10-27Viet Phu Trade and Import Export Co., …Disposable Vinyl Examination Gloves—
K2525052025-08-28Basic Medical Technology, Inc.Powder-Free Vinyl Exam Gloves, clearPDF
K2412522024-05-20Anqing Pukang Medical Technology Co., …Disposable Vinyl Examination GlovesPDF

3 summaries are archived here for direct download.

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