Home / 510(k) Clearances / K873457

510(k) K873457

SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS by Procter & Gamble Mfg. Co. — Product Code HIL

K873457 is an FDA 510(k) premarket notification submitted by Procter & Gamble Mfg. Co. for the device "SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS". The FDA issued a decision of Substantially Equivalent on January 19, 1988. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Procter & Gamble Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1988
Date Received
August 28, 1987
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 Procter & Gamble Mfg. Co.

  • K873036 — ATTENDS INCONTINENT BRIEF (January 19, 1988)
  • K864673 — UNSCENTED MENSTRUAL PAD (January 21, 1987)
  • K861863 — MODIFIED PROTECTIVE GARMENT (August 11, 1986)
  • K862348 — SINGLE-USE PATIENT UNDERPAD (July 2, 1986)
  • K860598 — MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS (March 5, 1986)
  • K853880 — ATTENDS DISPOS. UNDERPAD (October 16, 1985)
  • K853000 — SCENTED ALWAYS PANTILINERS (September 6, 1985)
  • K852985 — UNSCENTED ALWAYS PANTILINERS (August 29, 1985)
  • K850940 — ALWAYS SUPER MAXIPAD-UNSCENTED (May 14, 1985)
  • K850955 — ALWAYS MAXIPADS - UNSCENTED (May 14, 1985)

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)
  • K051446 — FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS (July 14, 2005)

FDA data resources