Cleared Traditional

K202706 - Surgical Gown (Sterile)

K202706 is an FDA 510(k) clearance for Surgical Gown (Sterile), manufactured by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K202706 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
106d
Days
Class 2
Risk

K202706 is an FDA 510(k) clearance for the Surgical Gown (Sterile), Surgical Gown (Non-sterile). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 31, 2020 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. devices

FDA 510(k) Submission Details - K202706

510(k) Number K202706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2020
Decision Date December 31, 2020
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

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 - FYA Gown, Surgical

All 165
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K202706.
Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
K211422 · Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · Jul 2021
Medline Orbis Surgical Gown
K202447 · Medline Industries, Inc. · Apr 2021
Medical Surgical Gowns
K202844 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Jan 2021
Modular Toga
K200977 · Operating Room Innovations, Inc. · Aug 2020
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
K200824 · Cardinal Health200, LLC · Jul 2020
Surgical Gown
K192560 · Shandong Kangli Medical Equipment Technology Co., Ltd. · May 2020