FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

PATIENT EXAM GLOVES(MFG: YUNG CHIEH ENTERPRISE)

K Number: K904839 · Decision Feb 12, 1991
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
1
Review Days
117

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Basic Information

Device Name
PATIENT EXAM GLOVES(MFG: YUNG CHIEH ENTERPRISE)
K Number
K904839
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6250
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Up TO Date, Inc.
Date Received
October 18, 1990
Decision Date
February 12, 1991
Product Code
LYY
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LYY Latex Patient Examination Glove

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