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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 K891300
Device Name NON-STERILE PATIENT EXAMINATION GLOVE
Applicant
Shun Thai Rubber Gloves Industry Co., Ltd.
238/1 Ratchada-Pisek Rd.
Huay-Kwang, Bangkok 10310
Thailand,  TH
Applicant Contact LUCKCHAI KITTIPOL
Correspondent
Shun Thai Rubber Gloves Industry Co., Ltd.
238/1 Ratchada-Pisek Rd.
Huay-Kwang, Bangkok 10310
Thailand,  TH
Correspondent Contact LUCKCHAI KITTIPOL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/13/1989
Decision Date 04/05/1989
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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