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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K922515
Device Name PROFEEL ANATOM SURG GLOVES (POWDER FREE/HYPOALLER)
Applicant
Wembley Rubber Products (M) Sdn Bhd
11th Floor, Menara Apera Ulg
84, Jalan Raja Chulan 50200
Kuala Lumpur, Malaysia,  MY
Applicant Contact KUEI CHOO
Correspondent
Wembley Rubber Products (M) Sdn Bhd
11th Floor, Menara Apera Ulg
84, Jalan Raja Chulan 50200
Kuala Lumpur, Malaysia,  MY
Correspondent Contact KUEI CHOO
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/27/1992
Decision Date 11/25/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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