Home / 510(k) Clearances / K161877

510(k) K161877

Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl by First Quality Hygienic, Inc. — Product Code HEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2016
Date Received
July 8, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

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 First Quality Hygienic, Inc.

  • K151470 — Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Abso (November 2, 2015)
  • K051446 — FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS (July 14, 2005)
  • K050660 — FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS (May 12, 2005)
  • K050067 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (February 1, 2005)
  • K032173 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (September 3, 2003)
  • K031067 — FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS (July 14, 2003)
  • K023479 — FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACK (November 26, 2002)
  • K963034 — FEMTEX GENTLE TOUCH TAMPONS (November 1, 1996)
  • K963032 — FREE CHOICE (October 11, 1996)
  • K920238 — PRIVATE LABELS AND FEMTEX (August 2, 1993)

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)