Cleared Traditional

K050660 - FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS

K050660 is an FDA 510(k) clearance for FEMTEX AND PRIVATE LABEL PLASTIC APPLIC..., 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 58-day FDA review.

K050660 · First Quality Hygienic, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
58d
Days
Class 2
Risk

K050660 is an FDA 510(k) clearance for the FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR 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 May 12, 2005 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all First Quality Hygienic, Inc. devices

FDA 510(k) Submission Details - K050660

510(k) Number K050660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2005
Decision Date May 12, 2005
Days to Decision 58 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 160d · This submission: 58d
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 137
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K050660.
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
K062638 · Procter & Gamble Co. · Nov 2006
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
K061486 · Procter & Gamble Co. · Aug 2006
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)
K051290 · Procter & Gamble Co. · Dec 2005
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
K040999 · Procter & Gamble Co. · Jul 2004
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
K032636 · Playtex Products, Inc. · Nov 2003
VIPON TAMPON
K992493 · Another Way Products, LLC · Nov 2000