FDA 510(k), K970794, LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)

FDA 510(k), K970794, LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)

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510(K) Number: K970794
Device Name: LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
Manufacturer: SIAM SEMPERMED CORP. LTD.
Device Classification Name: latex patient examination glove
Regulation Number: 880.6250
Classification Product Code: LYY
Date Received: 03/04/1997
Decision Date: 05/06/1997
Regulation Medical Specialty: General Hospital
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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