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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 K902017
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Taksin Rubber Industries Co., Ltd.
139-141 Niphat Uthit 2 Rd.
Haadyai Songkhla 90110
Thailand,  TH
Applicant Contact LAPSAK LAPAROJKIT
Correspondent
Taksin Rubber Industries Co., Ltd.
139-141 Niphat Uthit 2 Rd.
Haadyai Songkhla 90110
Thailand,  TH
Correspondent Contact LAPSAK LAPAROJKIT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/03/1990
Decision Date 05/18/1990
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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