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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 K082691
Device Name POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
Hebei Handform Plastic Products Co., Ltd.
Rm. 1606 Bldg. 1, Jianxiang
Yuan, No 209, Bei Si Huan
Zhong Road; Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Hebei Handform Plastic Products Co., Ltd.
Rm. 1606 Bldg. 1, Jianxiang
Yuan, No 209, Bei Si Huan
Zhong Road; Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/15/2008
Decision Date 02/04/2009
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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