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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 K891268
Device Name BIOSHIELD AND UNIVERSAL LATEX EXAM GLOVES
Applicant
Dah Lee Rubber Industries (Thai) , Ltd.
2f, 211 Chung Shiao E. Rd.
Section 3
Taipei, Taiwan R.O.C.,  TW
Applicant Contact K CHEN
Correspondent
Dah Lee Rubber Industries (Thai) , Ltd.
2f, 211 Chung Shiao E. Rd.
Section 3
Taipei, Taiwan R.O.C.,  TW
Correspondent Contact K CHEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/09/1989
Decision Date 08/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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