Cleared Traditional

K221819 - 35g Standard SMMS Surgical Gown (FDA 510(k) Clearance)

Also includes:
35g Reinforced SMMS Surgical Gown 43g Standard SMMS Surgical Gown 43g Reinforced SMMS Surgical Gown 50g Standard SMMS Surgical Gown 50g Reinforced SMMS Surgical Gown BVB Surgical Gown

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

K221819 · Winner Medical Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
88d
Days
Class 2
Risk

K221819 is an FDA 510(k) clearance for the 35g Standard SMMS Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Winner Medical Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on September 19, 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 Winner Medical Co., Ltd. devices

Submission Details

510(k) Number K221819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2022
Decision Date September 19, 2022
Days to Decision 88 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
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

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 292
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