FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

LATEX EXAMINATION GLOVES

K Number: K901579 · Decision Jun 28, 1990
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
2
Review Days
85

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Basic Information

Device Name
LATEX EXAMINATION GLOVES
K Number
K901579
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6250
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
P.T. Perkebunan
Date Received
April 4, 1990
Decision Date
June 28, 1990
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 P.T. Perkebunan

K Number Device Name
K902463 RUBIN PATIENT EXAMINATION GLOVES