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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 K891493
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Cinderella Ent. Co., Ltd.
# 10, Aly. 805, Er Hsi Rd.
Fang Yuan
Chang Hua,  TW
Applicant Contact YAN LIU
Correspondent
Cinderella Ent. Co., Ltd.
# 10, Aly. 805, Er Hsi Rd.
Fang Yuan
Chang Hua,  TW
Correspondent Contact YAN LIU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/16/1989
Decision Date 12/01/1989
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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