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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 K992463
Device Name SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
Shijiazhuang Dilly Plastics Products Co., Ltd.
# 16 Zhi Nong Rd.
Shijiazhuang,  CN 050051
Applicant Contact XINGLAI ZHOU
Correspondent
Shijiazhuang Dilly Plastics Products Co., Ltd.
# 16 Zhi Nong Rd.
Shijiazhuang,  CN 050051
Correspondent Contact XINGLAI ZHOU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/23/1999
Decision Date 08/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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