Vinyl Patient Examination Glove

LYZ · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6250

Classification

FDA Product Code: LYZ
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 880.6250
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 799
Registered establishments: 130

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown