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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K891513
Device Name VINYL EXAMINATION GLOVES
Applicant
Mann Chi Trading Co., Ltd.
Rm. 11, 9f.
# 163 Lin Sen 1st., Rd.
Kaohsiung, Taiwan R.O.C.,  TW
Applicant Contact DING
Correspondent
Mann Chi Trading Co., Ltd.
Rm. 11, 9f.
# 163 Lin Sen 1st., Rd.
Kaohsiung, Taiwan R.O.C.,  TW
Correspondent Contact DING
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/16/1989
Decision Date 09/26/1989
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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