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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 K893302
Device Name LATEX EXAMINATION GLOVES
Applicant
Gromax Rubber Industry Co., Ltd.
198-1 Nan-Fong Rd. Ping-Chen
Ind. Zone, Ping-Chen Hsiang
Tao-Yuan County, Taiwan,  TW
Applicant Contact DAVID LEE
Correspondent
Gromax Rubber Industry Co., Ltd.
198-1 Nan-Fong Rd. Ping-Chen
Ind. Zone, Ping-Chen Hsiang
Tao-Yuan County, Taiwan,  TW
Correspondent Contact DAVID LEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/18/1989
Decision Date 09/13/1989
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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