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510(k) K890655

NEW FREEDOM THIN DEODORANT MAXI PADS by Kimberly-Clark Corp. — Product Code HHL

K890655 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "NEW FREEDOM THIN DEODORANT MAXI PADS". The FDA issued a decision of Substantially Equivalent on May 1, 1989. The device falls under product code HHL (Pad, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5425. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1989
Date Received
February 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Menstrual, Scented, Scented-Deodorized
Device Class
Class II
Regulation Number
884.5425
Review Panel
OB
Submission Type

Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).

Other clearances by Kimberly-Clark Corp.

  • K140963 — KIMGUARD SMART-FOLD STERILIZATION WRAP (November 10, 2014)
  • K141294 — U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS (August 25, 2014)
  • K131879 — KC 300 SURGICAL MASK (December 20, 2013)
  • K131841 — KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE (November 7, 2013)
  • K131254 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE (August 20, 2013)
  • K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING (December 19, 2012)
  • K112805 — KIMGUARD ONE-STEP STERILIZATION WRAP (June 22, 2012)
  • K113340 — KIMBERLY-CLARK CHILD'S FACEMASK (May 4, 2012)
  • K113423 — KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE (March 9, 2012)
  • K112300 — KIMGUARD SMART-FOLD* STERILIZATION WRAP (January 19, 2012)

Other clearances for product code HHL

  • K962953 — DEODORANT PANTY SHIELD (October 10, 1996)
  • K962954 — DEODORANT MAXI PAD (October 10, 1996)
  • K962962 — DEODORANT PANTY LINER (October 10, 1996)
  • K961119 — CAREFREE PANTYLINERS (April 17, 1996)
  • K913237 — ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD (September 23, 1991)
  • K913238 — ALWAYS, UNSCENTED MENSTRUAL PAD (September 23, 1991)
  • K891473 — TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO (June 7, 1989)
  • K884951 — TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT (January 10, 1989)
  • K884446 — MAXITHINS SUPER PADS, DEODORANT (December 20, 1988)
  • K884444 — MAXITHINS REGULAR PADS, DEODORANT (December 5, 1988)

FDA data resources