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

LATEX EXAM GLOVES (MFG. GLOVELINE INDUSTRIES)

K Number: K893277 · Decision Aug 9, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
1
Review Days
114

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Basic Information

Device Name
LATEX EXAM GLOVES (MFG. GLOVELINE INDUSTRIES)
K Number
K893277
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6250
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
China Representatives , Ltd.
Date Received
April 17, 1989
Decision Date
August 9, 1989
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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