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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 K891277
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Grace River Ent., Inc.
P.O. Box 712
Murray Hill Station,  NY  10156
Applicant Contact GRACE SHIH
Correspondent
Grace River Ent., Inc.
P.O. Box 712
Murray Hill Station,  NY  10156
Correspondent Contact GRACE SHIH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/15/1989
Decision Date 01/11/1990
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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