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

BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW

K Number: K032323 · Decision Oct 7, 2003
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
795
Applicant Total
1
Review Days
71

Basic Information

Device Name
BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
K Number
K032323
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6250
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
LONG FIRST (XIAMEN) PLASTICS CO., LTD.
Date Received
July 28, 2003
Decision Date
October 7, 2003
Product Code
LYZ
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
LYZ Vinyl Patient Examination Glove

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