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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 K891720
Device Name PULLTEX BRAND (PATIENT EXAM GLOVES - LATEX)
Applicant
Pulley Rubber Corp.
# 10, Gong-Yeh N. Rd.
Nan Kang Industrial Zone
Nantou, Taiwan, R.O.C.,  TW
Applicant Contact HSIEN-PEI, LIN
Correspondent
Pulley Rubber Corp.
# 10, Gong-Yeh N. Rd.
Nan Kang Industrial Zone
Nantou, Taiwan, R.O.C.,  TW
Correspondent Contact HSIEN-PEI, LIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/21/1989
Decision Date 07/14/1989
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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