LYZ — Vinyl Patient Examination Glove Class I

FDA Device Classification

Classification Details

Product Code
LYZ
Device Class
Class I
Regulation Number
880.6250
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252467viet phu trade and import export coDisposable Vinyl Examination GlovesOctober 27, 2025
K252505basic medical technologyPowder-Free Vinyl Exam Gloves, clearAugust 28, 2025
K241252anqing pukang medical technology coDisposable Vinyl Examination GlovesMay 20, 2024
K230046guangdong kingfa sci. and tech.coVinyl examination glovesMarch 25, 2023
K221980ever global (vietnam) enterprise corporationDisposable Powder Free Vinyl Examination Gloves, Beige/ClearFebruary 6, 2023
K220992ever global (vietnam) enterprise corporationDisposable Powder Free Vinyl Exam Glove, Black/Blue/PurpleOctober 19, 2022
K223008jiangxi handspro products solutions coDisposable Vinyl Examination GlovesOctober 8, 2022
K222442anhui bytech medical supplies coDISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)September 28, 2022
K220055dezhou hengchang medical technology coDisposable, vinyl examination gloves, YellowAugust 25, 2022
K220469chifeng huawei medical science and technology coDisposable Vinyl Examination GloveJune 16, 2022
K220240grand work plastic products coVinyl Co-Polymer Powder-free Examination Gloves, BlackMarch 31, 2022
K213634dezhou hengchang medical technology coVinyl/Nitrile Blend Exam GloveFebruary 18, 2022
K213625dezhou hengchang medical technology coVinyl Examination GlovesFebruary 17, 2022
K212011top glove vietnam company limitedVinyl Powder Free Examination GloveFebruary 14, 2022
K213019hebei astro medical supply coVinyl Exam GlovesJanuary 5, 2022
K212436shandong langtai international trade coNBR Synthetic Nitrile Examination GlovesDecember 23, 2021
K213144shen wei usaBiodegradable Powder Free Vinyl Examination Gloves Blue, Green and White ColorsDecember 22, 2021
K213006taian hengchang medical technology coVinyl Examination GlovesDecember 21, 2021
K211865liao ning shangwei medical products coPowder Free Vinyl Patient Examination Gloves, Clear (non-colored)December 20, 2021
K212899bytech(dongtai) coDisposable Vinyl/Nitrile Blend Medical Examination GlovesDecember 11, 2021