Home / 510(k) Clearances / K051446

510(k) K051446

FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS by First Quality Hygienic, Inc. — Product Code HIL

K051446 is an FDA 510(k) premarket notification submitted by First Quality Hygienic, Inc. for the device "FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS". The FDA issued a decision of Substantially Equivalent on July 14, 2005. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. First Quality Hygienic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2005
Date Received
June 2, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tampon, Menstrual, Scented, Scented-Deodorized
Device Class
Class II
Regulation Number
884.5460
Review Panel
OB
Submission Type

A scented or scented-deodorized 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.

  • K161877 — Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon (August 5, 2016)
  • K151470 — Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Abso (November 2, 2015)
  • 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 HIL

  • K132208 — ONTEX AND OTHERS PROPRIETARY NAMES (April 10, 2014)
  • K132819 — PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (October 9, 2013)
  • K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (June 21, 2012)
  • K111684 — PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD (February 3, 2012)
  • K081555 — TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED (June 27, 2008)
  • K073662 — PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS (January 17, 2008)
  • K072376 — PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS (December 12, 2007)
  • K070745 — MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK (April 13, 2007)
  • K060981 — PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS (May 9, 2006)
  • K050067 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (February 1, 2005)

FDA data resources