Cleared Traditional

K050067 - FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS

K050067 is an FDA 510(k) clearance for FEMTEX AND PRIVATE LABEL SCENTED PLASTI..., manufactured by First Quality Hygienic, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIL cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K050067 · 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
Feb 2005
Decision
20d
Days
Class 2
Risk

K050067 is an FDA 510(k) clearance for the FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by First Quality Hygienic, Inc. (Allendale, US). The FDA issued a Cleared decision on February 1, 2005 after a review of 20 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. 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.

FDA 510(k) Submission Details - K050067

510(k) Number K050067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2005
Decision Date February 01, 2005
Days to Decision 20 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
141d faster than avg
Panel avg: 161d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 79
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K050067.
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
K070745 · Playtex Products, Inc. · Apr 2007
PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
K060981 · Playtex Products, Inc. · May 2006
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
K051446 · First Quality Hygienic, Inc. · Jul 2005
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
K042773 · Rostam , Ltd. · Nov 2004
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
K050067 · FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
Download PDF FDA Summary First Quality Hygieni…