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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 K993567
Device Name INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]
Applicant
INNOVATIVE GLOVES CO; LTD
11 CHOTEVITTAYAKUL 3 RD.
HATYAI, SONGKHLA,  TH
Applicant Contact RAJEEV KUMAR SOOD
Correspondent
INNOVATIVE GLOVES CO; LTD
11 CHOTEVITTAYAKUL 3 RD.
HATYAI, SONGKHLA,  TH
Correspondent Contact RAJEEV KUMAR SOOD
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/21/1999
Decision Date 01/12/2000
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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