Cleared Special

K022882 - MODIFICATION TO PLAYTEX TAMPONS #24002

K022882 is an FDA 510(k) clearance for MODIFICATION TO PLAYTEX TAMPONS #24002, manufactured by Playtex Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIL cleared through the Special 510(k) pathway after a 17-day FDA review.

K022882 · Playtex Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
17d
Days
Class 2
Risk

K022882 is an FDA 510(k) clearance for the MODIFICATION TO PLAYTEX TAMPONS #24002. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Playtex Products, Inc. (Allendale, US). The FDA issued a Cleared decision on September 16, 2002 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5460 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022882

510(k) Number K022882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2002
Decision Date September 16, 2002
Days to Decision 17 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d faster than avg
Panel avg: 161d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

HIL Device Classification - Class 2, Special Controls

Product Code HIL Tampon, Menstrual, Scented, Scented-deodorized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5460
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIL Tampon, Menstrual, Scented, Scented-deodorized

All 77
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K022882.
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
K040312 · Procter & Gamble Co. · May 2004
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
K032173 · First Quality Hygienic, Inc. · Sep 2003
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
K032080 · Rostam , Ltd. · Aug 2003
PLAYTEX DEODORANT TAMPONS, MODEL 34802
K020200 · Playtex Products, Inc. · Mar 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34902
K020201 · Playtex Products, Inc. · Mar 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34702
K020202 · Playtex Products, Inc. · Mar 2002