FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇳 India

LATEX EXAMINATION GLOVES

K Number: K893937 · Decision Nov 21, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
1
Review Days
174

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Basic Information

Device Name
LATEX EXAMINATION GLOVES
K Number
K893937
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6250
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Sai Latex Private , Ltd.
Date Received
May 31, 1989
Decision Date
November 21, 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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