Cleared Traditional

K031067 - FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS

K031067 is an FDA 510(k) clearance for FEMTEX JUNIOR/SLENDER REGULAR OPEN-END ..., manufactured by First Quality Hygienic, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K031067 · First Quality Hygienic, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
101d
Days
Class 2
Risk

K031067 is an FDA 510(k) clearance for the FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by First Quality Hygienic, Inc. (Allendale, US). The FDA issued a Cleared decision on July 14, 2003 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5470 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K031067

510(k) Number K031067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2003
Decision Date July 14, 2003
Days to Decision 101 days
Submission Type Traditional
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
60d faster than avg
Panel avg: 161d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEB Device Classification - Class 2, Special Controls

Product Code HEB Tampon, Menstrual, Unscented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5470
Definition An Unscented 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 - HEB Tampon, Menstrual, Unscented

All 179
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K031067.
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
K040999 · Procter & Gamble Co. · Jul 2004
PH BUFFERING PLASTIC APPLICATOR TAMPON
K030474 · Rostam , Ltd. · May 2004
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
K032636 · Playtex Products, Inc. · Nov 2003
O.B. TAMPONS
K023789 · Mcneil-Ppc, Inc. · Dec 2002
FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K023479 · First Quality Hygienic, Inc. · Nov 2002
INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K020535 · Rostam , Ltd. · May 2002
K031067 · FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS
Download PDF FDA Summary First Quality Hygieni…