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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 K990751
Device Name SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES
Applicant
Southland Products Co., Ltd.
55 Rajyindee Rd.
Hatyai, Songkhla,  TH 90110
Applicant Contact NG PENG LEONG
Correspondent
Southland Products Co., Ltd.
55 Rajyindee Rd.
Hatyai, Songkhla,  TH 90110
Correspondent Contact NG PENG LEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/08/1999
Decision Date 03/23/1999
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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