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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 K894025
Device Name VINYL EXAMINATION GLOVES (NON-STERILE)
Applicant
Good Glove Corp.
1110-145. Lin Hai Rd.
Tung Hai Tson, Fang Liao
Hsiang, Pingtung County,  TW
Applicant Contact MAX MA
Correspondent
Good Glove Corp.
1110-145. Lin Hai Rd.
Tung Hai Tson, Fang Liao
Hsiang, Pingtung County,  TW
Correspondent Contact MAX MA
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/06/1989
Decision Date 09/11/1989
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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