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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name polymer patient examination glove
510(k) Number K001155
Device Name DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
Applicant
SHEEN MORE ENT. CO., LTD.
NO.16, TOU KUNG SIX RD.
TOU-LIU EXPANDED INDUST. PARK
TOU-LIU, YUN-LIN,  TW
Applicant Contact KEN HUANG
Correspondent
SHEEN MORE ENT. CO., LTD.
NO.16, TOU KUNG SIX RD.
TOU-LIU EXPANDED INDUST. PARK
TOU-LIU, YUN-LIN,  TW
Correspondent Contact KEN HUANG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/10/2000
Decision Date 05/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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