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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 K910774
Device Name AM GLOVES STERILE VINYL EXAMINATION
Applicant
Am Gloves Co., Ltd.
10th Floor , No 50 Fu Hsing N. Rd.
Taipei, Taiwan, R.O.C.,  CN
Applicant Contact TAMMY PHONE
Correspondent
Am Gloves Co., Ltd.
10th Floor , No 50 Fu Hsing N. Rd.
Taipei, Taiwan, R.O.C.,  CN
Correspondent Contact TAMMY PHONE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/22/1991
Decision Date 03/07/1991
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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