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510(k) K962953

DEODORANT PANTY SHIELD by Paragon Trade Brands, Inc. — Product Code HHL

K962953 is an FDA 510(k) premarket notification submitted by Paragon Trade Brands, Inc. for the device "DEODORANT PANTY SHIELD". The FDA issued a decision of Substantially Equivalent on October 10, 1996. The device falls under product code HHL (Pad, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5425. Paragon Trade Brands, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1996
Date Received
July 30, 1996
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 Paragon Trade Brands, Inc.

  • K983381 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS (October 19, 1998)
  • K981953 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS (August 18, 1998)
  • K962954 — DEODORANT MAXI PAD (October 10, 1996)
  • K962962 — DEODORANT PANTY LINER (October 10, 1996)
  • K953333 — MENSTRUAL TAMPON (December 6, 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)
  • K953517 — UNSCENTED MENSTRUAL PAD (October 26, 1995)
  • K953666 — UNSCENTED MENSTRAL PAD WITH WINGS (September 27, 1995)

Other clearances for product code HHL

  • K962954 — DEODORANT MAXI PAD (October 10, 1996)
  • K962962 — DEODORANT PANTY LINER (October 10, 1996)
  • K961119 — CAREFREE PANTYLINERS (April 17, 1996)
  • K913237 — ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD (September 23, 1991)
  • K913238 — ALWAYS, UNSCENTED 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