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510(k) K913238

ALWAYS, UNSCENTED MENSTRUAL PAD by Procter & Gamble Co. — Product Code HHL

K913238 is an FDA 510(k) premarket notification submitted by Procter & Gamble Co. for the device "ALWAYS, UNSCENTED MENSTRUAL PAD". The FDA issued a decision of Substantially Equivalent on September 23, 1991. The device falls under product code HHL (Pad, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5425. Procter & Gamble Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1991
Date Received
July 22, 1991
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 Procter & Gamble Co.

  • K203567 — Oral-B Dry Mouth Oral Rinse (April 5, 2021)
  • K201277 — Oral-B Dry Mouth Oral Rinse (September 2, 2020)
  • K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit (August 27, 2020)
  • K151413 — Always/Tampax bladder supports (December 18, 2015)
  • K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBR (September 15, 2014)
  • K133244 — TAMPAX M PLASTIC TAMPONS, UNSCENTED (January 9, 2014)
  • K131543 — TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED (June 20, 2013)
  • K113699 — TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED (January 12, 2012)
  • K110669 — TAMPAX C PLASTIC TAMPONS, UNSCENTED (June 2, 2011)
  • K091281 — TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL (June 1, 2010)

Other clearances for product code HHL

  • K962962 — DEODORANT PANTY LINER (October 10, 1996)
  • K962954 — DEODORANT MAXI PAD (October 10, 1996)
  • K962953 — DEODORANT PANTY SHIELD (October 10, 1996)
  • K961119 — CAREFREE PANTYLINERS (April 17, 1996)
  • K913237 — ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD (September 23, 1991)
  • K891473 — TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO (June 7, 1989)
  • K890655 — NEW FREEDOM THIN DEODORANT MAXI PADS (May 1, 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