LZB — Finger Cot Class I

FDA Device Classification

FDA product code LZB covers "Finger Cot", a Class I medical device regulated under 21 CFR 880.6250. Submissions are reviewed by the General Hospital panel. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K052387arthrexARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XXNovember 29, 2005
K992539digit-proPERCUGUARDFebruary 18, 2000
K980827tucker and associatesLATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELINGMay 4, 1998
K912042bethel latex productsBETHEL PLUS MULTIPLE NAMESJuly 2, 1991
K903073dongkuk trading coLATEX FINGER COTSSeptember 12, 1990