Cleared Traditional

K050360 - TULIP CONDOM

K050360 is an FDA 510(k) clearance for TULIP CONDOM, manufactured by Shanghai Latex Factory. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K050360 · Shanghai Latex Factory · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
15d
Days
Class 2
Risk

K050360 is an FDA 510(k) clearance for the TULIP CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Shanghai Latex Factory (Shanghai, CN). The FDA issued a Cleared decision on March 1, 2005 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - 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 - K050360

510(k) Number K050360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date March 01, 2005
Days to Decision 15 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 161d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
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 Consultant

Tuv America, Inc.
LAURA L DANIELSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIS Condom

All 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K050360.
DIVAS DUAL PLEASURE MALE LATEX CONDOM
K051273 · Eagle Twe, Inc. · Aug 2005
MALE NATURAL RUBBER LATEX CONDOM
K050244 · Nrs Global Partners · Apr 2005
DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM
K042470 · Ssl Americas, Inc. · Apr 2005
DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
K042957 · Ssl Americas · Feb 2005
SAN-MAR LABS LUBRICATING JELLY
K041667 · San-Mar Laboratories, Inc. · Jan 2005
POWERSTICK MALE LATEX CONDOMS
K041717 · A.P.Deauville, LLC · Jan 2005

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K050360 · TULIP CONDOM
Download PDF FDA Summary Shanghai Latex Factory