510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962953Substantially Equivalent

Deodorant Panty Shield

Paragon Trade Brands, Inc., Gaffney SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962953 is the FDA 510(k) clearance record for DEODORANT PANTY SHIELD, a class II device, cleared for Paragon Trade Brands, Inc. on under FDA product code HHL (Pad, Menstrual, Scented, Scented-Deodorized). FDA's definition for product code HHL reads: "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...". FDA records list 14 510(k) clearances for Paragon Trade Brands, Inc., from to . As of , FDA records show no recalls naming K962953.

Clearance record

Decision date
Received
(72 days to decision)
Product code
HHL Pad, Menstrual, Scented, Scented-Deodorized
Regulation
21 CFR 884.5425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Paragon Trade Brands, Inc. 10 Commerce Dr., Gaffney SC
510(k) summary
Statement
Third party review
No

Clearances, product code HHL

Trailing 12 months

FDA records hold no clearances under product code HHL in the trailing twelve months.

FDA records show no clearances under product code HHL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260