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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K920202
Device Name LATEX EXAM/SURGICAL GLOVES
Applicant
Redsun Latex , Ltd.
B-211 Brindawan Aprtments
Niloufer Hospital Ln.
Red Hills, Hyderabad, Ind,  IN 500 004
Applicant Contact RAMAKUMARI
Correspondent
Redsun Latex , Ltd.
B-211 Brindawan Aprtments
Niloufer Hospital Ln.
Red Hills, Hyderabad, Ind,  IN 500 004
Correspondent Contact RAMAKUMARI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/15/1992
Decision Date 07/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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