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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 K891938
Device Name NON-STERILE PATIENT EXAMINATION GLOVES
Applicant
Lien Chang Rubber Industrial Co., Ltd.
16, Ln. 472, Sec 4, Chang
Shui Rd. Hsing Nung Village
Pai Tu Hsiang, Chang Hua,  TW
Applicant Contact J. P CHEN
Correspondent
Lien Chang Rubber Industrial Co., Ltd.
16, Ln. 472, Sec 4, Chang
Shui Rd. Hsing Nung Village
Pai Tu Hsiang, Chang Hua,  TW
Correspondent Contact J. P CHEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/28/1989
Decision Date 05/08/1989
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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