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

WINFIELD LATEX EXAMINATION GLOVES

K Number: K891855 · Decision Jun 22, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
5
Review Days
87

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Basic Information

Device Name
WINFIELD LATEX EXAMINATION GLOVES
K Number
K891855
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6250
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Winfield Co., Inc.
Date Received
March 27, 1989
Decision Date
June 22, 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

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (LYY), ordered by most recent decision date.

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Other Clearances by Winfield Co., Inc.

K Number Device Name
K942902 SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER
K942901 SHARPS-TAINER LARGE OPENING
K942903 SHARPS-TAINER SMALL OPENING
K802803 CONVALESCENT RECLINER