Cleared Traditional

Surgical Gown, Model: surgical gown-hp-3 (K210355) - FDA 510(k) Clearance

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

K210355 · Weihai Dishang Medical Technology Co., Ltd. · General Hospital
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Dec 2021
Decision
311d
Days
Class 2
Risk

K210355 is an FDA 510(k) clearance for the Surgical Gown, Model: surgical gown-hp-3. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Weihai Dishang Medical Technology Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on December 16, 2021 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Weihai Dishang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K210355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2021
Decision Date December 16, 2021
Days to Decision 311 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
182d slower than avg
Panel avg: 129d · This submission: 311d
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 Peers - FYA Gown, Surgical

All 105
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K210355.
EndoArmor™ + Surgical Gown
K203548 · Boston Scientific Corporation · Feb 2022
Surgical gowns
K212718 · Xiantao Dingcheng Non-Woven Product Co., Ltd. · Jan 2022
Disposable Surgical Gown
K212591 · Suzhou Janee Medical Technology Co., Ltd. · Jan 2022
Surgical Gown, Reinforced Surgical Gown
K212861 · Wuhan Zonsen Medical Products Co., Ltd. · Dec 2021
Disposable Surgical Gown, Disposable Reinforced Surgical Gown
K212869 · Fugou County Shenxiang Manufacturing Co., Ltd. · Dec 2021
Disposable Surgical Gown
K212925 · Henan Robestain Medical Products Co., Ltd. · Dec 2021