Cleared Traditional

Surgical Gown, Reinforced Surgical Gown (K212861) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212861 · Wuhan Zonsen Medical Products Co., Ltd. · General Hospital
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Dec 2021
Decision
98d
Days
Class 2
Risk

K212861 is an FDA 510(k) clearance for the Surgical Gown, Reinforced Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Wuhan Zonsen Medical Products Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on December 15, 2021 after a review of 98 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 Wuhan Zonsen Medical Products Co., Ltd. devices

Submission Details

510(k) Number K212861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2021
Decision Date December 15, 2021
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Shanghai Sungo Management Consulting Company Limited.
Ivy Wang

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 105
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K212861.
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K212869 · Fugou County Shenxiang Manufacturing Co., Ltd. · Dec 2021
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K212925 · Henan Robestain Medical Products Co., Ltd. · Dec 2021
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
K203539 · Unicoglobal, Inc. · Dec 2021