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510(k) K844601

UNSCENTED MENSTRUAL PAD by Procter & Gamble Mfg. Co. — Product Code HHD

K844601 is an FDA 510(k) premarket notification submitted by Procter & Gamble Mfg. Co. for the device "UNSCENTED MENSTRUAL PAD". The FDA issued a decision of Substantially Equivalent on January 16, 1985. The device falls under product code HHD (Pad, Menstrual, Unscented), a Class I device regulated under 21 CFR 884.5435. Procter & Gamble Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1985
Date Received
November 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Menstrual, Unscented
Device Class
Class I
Regulation Number
884.5435
Review Panel
OB
Submission Type

An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.

Other clearances by Procter & Gamble Mfg. Co.

  • K873457 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (January 19, 1988)
  • 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)
  • K850955 — ALWAYS MAXIPADS - UNSCENTED (May 14, 1985)

Other clearances for product code HHD

  • K071827 — ALWAYS MENSTRUAL PADS (September 20, 2007)
  • K012629 — ALWAYS DUETS (October 5, 2001)
  • K003843 — ENVIVE MINIFORMS (February 8, 2001)
  • K993870 — UNSCENTED INTERLABIAL MENSTRUAL PAD (January 18, 2000)
  • K980395 — GLADRAGS COTTON MENSTRUAL PAD (April 16, 1998)
  • K953470 — FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) (November 21, 1995)
  • K953633 — UNSCENTED MENSTRUAL PAD (November 1, 1995)
  • K953668 — UNSCENTED ULTRATHIN MAXI PAD (November 1, 1995)
  • K953667 — UNSCENTED CURVED ULTRATHIN MAXI PADS (November 1, 1995)
  • K953553 — UNSCENTED MENSTRAL PAD (October 27, 1995)

FDA data resources