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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 K915842
Device Name PATIENT EXAMINATION GLOVE
Applicant
Precious Mountain Ent. Corp.
10th Floor , # 50
Fu Hsing N. Rd. Taipei,
Taiwan R.O.C,  TW
Applicant Contact RICK LIN
Correspondent
Precious Mountain Ent. Corp.
10th Floor , # 50
Fu Hsing N. Rd. Taipei,
Taiwan R.O.C,  TW
Correspondent Contact RICK LIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/26/1991
Decision Date 04/14/1992
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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