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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 K890115
Device Name AMBI-DEX (LATEX EXAMINATION GLOVES)
Applicant
Globe Safety Products, Inc.
Flat 1-11, 6th Floor Kar Wah Ind
Bldg., Y.L.T.L. 356 Yuen Long
N.T. Hong Kong,  GB
Applicant Contact W. M SUNG
Correspondent
Globe Safety Products, Inc.
Flat 1-11, 6th Floor Kar Wah Ind
Bldg., Y.L.T.L. 356 Yuen Long
N.T. Hong Kong,  GB
Correspondent Contact W. M SUNG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/11/1989
Decision Date 09/01/1989
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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