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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 K891868
Device Name PATIENT EXAMINATION GLOVE (LATEX)
Applicant
Bber Sound Rubber Industrial Co., Ltd.
Prime Merit Int'L Corp.
1214d Santa Anita Ave.
S. El Monte,  CA  91733
Applicant Contact ERIC LO
Correspondent
Bber Sound Rubber Industrial Co., Ltd.
Prime Merit Int'L Corp.
1214d Santa Anita Ave.
S. El Monte,  CA  91733
Correspondent Contact ERIC LO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/27/1989
Decision Date 04/12/1989
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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