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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 K890982
Device Name BUTTERFLY GLOBE (PATIENT EXAMINATION GLOVE)
Applicant
O.L. Trading, Inc.
1534 N. Knowles Ave.
Los Angeles,  CA  90063
Applicant Contact PETER LO
Correspondent
O.L. Trading, Inc.
1534 N. Knowles Ave.
Los Angeles,  CA  90063
Correspondent Contact PETER LO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/27/1989
Decision Date 04/04/1989
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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