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510(k) K980478

PLAYTEX TAMPONS #03498 by Playtex, Inc. — Product Code HEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1998
Date Received
February 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tampon, Menstrual, Unscented
Device Class
Class II
Regulation Number
884.5470
Review Panel
OB
Submission Type

An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.

Other clearances by Playtex, Inc.

  • K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (June 21, 2012)
  • K971174 — PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS (May 21, 1997)
  • K944064 — PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894 (February 9, 1995)
  • K941044 — PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194 (July 27, 1994)
  • K942418 — PLAYTEX TAMPONS MODEL 13794 (July 8, 1994)
  • K881057 — PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER (March 22, 1988)
  • K874509 — PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL (January 7, 1988)
  • K843551 — PLAYTEX BABY POWDER DEODORANT TAMPONS (December 3, 1984)
  • K841155 — DEODORANT SLENDER REG. TAMPONS (March 19, 1984)
  • K841154 — PLAYTEX SLENDER REGULAR TAMPONS (March 19, 1984)

Other clearances for product code HEB

  • K253719 — Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applic (December 17, 2025)
  • K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (October 9, 2025)
  • K252613 — Unscented menstrual three-piece applicator tampon (September 19, 2025)
  • K251033 — Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicat (August 13, 2025)
  • K242105 — SABA Tampons (April 1, 2025)
  • K241064 — Unscented Tampon (January 10, 2025)
  • K240708 — Organic Cotton Tampon; Organic Cotton PESCVcord Tampon (May 10, 2024)
  • K232060 — TOSAMA Reusable Applicator (April 12, 2024)
  • K232598 — Unscented Menstrual Tampon (December 15, 2023)
  • K223883 — Daye Tampon (August 18, 2023)