FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

VITAL SURGICAL GLOVES

K Number: K901359 · Decision Apr 3, 1990
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
2
Review Days
11

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Basic Information

Device Name
VITAL SURGICAL GLOVES
K Number
K901359
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4460
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Mastervest Corp. Sdn Bhd.
Date Received
March 23, 1990
Decision Date
April 3, 1990
Product Code
KGO
Advisory Committee
General, Plastic Surgery
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
KGO Surgeon'S Gloves

Similar 510(k) Clearances

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Other Clearances by Mastervest Corp. Sdn Bhd.

K Number Device Name
K892679 PATIENT EXAMINATION GLOVES (LATEX)