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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K111158
Device Name LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Innovative Gloves Co;, Ltd.
830 Moo 4 Sanambin-Banklang Rd.
Kuanlang
Hatyai, Songkhla,  TH 90110
Applicant Contact RAJEEV SOOD
Correspondent
Innovative Gloves Co;, Ltd.
830 Moo 4 Sanambin-Banklang Rd.
Kuanlang
Hatyai, Songkhla,  TH 90110
Correspondent Contact RAJEEV SOOD
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/25/2011
Decision Date 08/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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