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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K891646
Device Name TOPLAS VINYL PATIENT EXAMINATION GLOVE
Applicant
Toplas Industrial Co., Ltd.
# 23, Wu Shiun St. Ta Wu
Luen Park
Keelung,  TW
Applicant Contact ALEX LIN
Correspondent
Toplas Industrial Co., Ltd.
# 23, Wu Shiun St. Ta Wu
Luen Park
Keelung,  TW
Correspondent Contact ALEX LIN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/17/1989
Decision Date 04/25/1989
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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