Cleared Traditional

K993794 - PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS

K993794 is an FDA 510(k) clearance for PLATEX ODER ABSORBING GENTLE GLIDE, manufactured by Playtime Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K993794 · Playtime Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
90d
Days
Class 2
Risk

K993794 is an FDA 510(k) clearance for the PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Playtime Products, Inc. (Allendale, US). The FDA issued a Cleared decision on February 7, 2000 after a review of 90 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.

View all Playtime Products, Inc. devices

FDA 510(k) Submission Details - K993794

510(k) Number K993794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1999
Decision Date February 07, 2000
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
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 136
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K993794.
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
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR
K002096 · Procter & Gamble Co. · Sep 2000
O.B. TAMPON
K990536 · Personal Products Co. · Aug 1999
O.B. APPLICATOR TAMPONS, O.B. TAMPONS
K991118 · Personal Products Co. · Jun 1999
ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
K983478 · Organic Essentials · Nov 1998