Cleared Abbreviated

K050887 - GONGDONG DISPOSABLE VAGINAL SPECULUM

K050887 is an FDA 510(k) clearance for GONGDONG DISPOSABLE VAGINAL SPECULUM, manufactured by Zhejiang Gongdong Medical Plastic Factory. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Abbreviated 510(k) pathway after a 95-day FDA review.

K050887 · Zhejiang Gongdong Medical Plastic Factory · Obstetrics & Gynecology device
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Jul 2005
Decision
95d
Days
Class 2
Risk

K050887 is an FDA 510(k) clearance for the GONGDONG DISPOSABLE VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Zhejiang Gongdong Medical Plastic Factory (Huangyan, Taizhou, Zhejiang, CN). The FDA issued a Cleared decision on July 11, 2005 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K050887

510(k) Number K050887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2005
Decision Date July 11, 2005
Days to Decision 95 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 161d · This submission: 95d
Pathway characteristics
Standards-based clearance path.

HIB Device Classification - Class 2, Special Controls

Product Code HIB Speculum, Vaginal, Nonmetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HIB Speculum, Vaginal, Nonmetal

All 62
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K050887.
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
K052192 · Femspec LLC · Feb 2006
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K052912 · Zhejiang Yusheng Medical Instrument Co. , Ltd. · Dec 2005
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K052314 · Dynarex Corp. · Nov 2005
FEMSPEC DISPOSABLE VAGINAL SPECULUM
K041757 · Femspec LLC · Dec 2004
VAG O SPECULUM, MODELS VS1, VM1, VL1
K042950 · Panatrex, Inc. · Nov 2004
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
K040817 · Advanced Urological Developments · Jun 2004
K050887 · GONGDONG DISPOSABLE VAGINAL SPECULUM
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