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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 K891670
Device Name HEDY PATIENT EXAMINATION GLOVES (VINYL)
Applicant
Hedd Industry Corp.
4f-1, # 106, Sec. 6
Roosevelt Rd.
Taipei (11720), Taiwan,  TW
Applicant Contact MIN-JEN CHEN
Correspondent
Hedd Industry Corp.
4f-1, # 106, Sec. 6
Roosevelt Rd.
Taipei (11720), Taiwan,  TW
Correspondent Contact MIN-JEN CHEN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/20/1989
Decision Date 10/31/1989
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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