Cleared Traditional

Surgical Gown (Sterile) (K221637) - FDA 510(k) Clearance

Also marketed or referenced as:
Surgical Gown (Non-sterile)

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

K221637 · Allmed Medical (Hubei) Protective Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
115d
Days
Class 2
Risk

K221637 is an FDA 510(k) clearance for the Surgical Gown (Sterile). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Allmed Medical (Hubei) Protective Products Co., Ltd. (Zhijiang, CN). The FDA issued a Cleared decision on September 29, 2022 after a review of 115 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 Allmed Medical (Hubei) Protective Products Co., Ltd. devices

Submission Details

510(k) Number K221637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2022
Decision Date September 29, 2022
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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 K221637.
Disposable Surgical Gown Rk-3011C
K211060 · Xiantao Rhycom Non-Woven Products Co., Ltd. · Oct 2022
Disposable Surgical Gown (G4003)
K221977 · Xiantao Topmed Nonwoven Protective Products Co., Ltd. · Oct 2022
YADU Surgical Gowns
K220092 · Henan Yadu Industrial Co., Ltd. · Oct 2022
Disposable Surgical Gown UM-148
K221717 · Unimax Medical Products Co., Ltd. · Sep 2022
35g Standard SMMS Surgical Gown
K221819 · Winner Medical Co., Ltd. · Sep 2022
Sterile Level 3 Surgical Gown
K211399 · Barco Tekstil Sanayi VE Ticaret A.S. · Jul 2022