Cleared Traditional

K220665 - Surgical Gown, Blue, Sterile (FDA 510(k) Clearance)

Also includes:
Surgical Gown, Blue, Non-Sterile

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

K220665 · Excellent Medical Technology Group Co., Ltd. · General Hospital
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Jun 2022
Decision
88d
Days
Class 2
Risk

K220665 is an FDA 510(k) clearance for the Surgical Gown, Blue, Sterile. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Excellent Medical Technology Group Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on June 3, 2022 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Excellent Medical Technology Group Co., Ltd. devices

Submission Details

510(k) Number K220665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2022
Decision Date June 03, 2022
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
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

Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Olivia Meng

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

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