Cleared Traditional

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (K221027) - FDA 510(k) Clearance

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

K221027 · Allmed Medical (Hubei) Protective Products Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2022
Decision
128d
Days
Class 2
Risk

K221027 is an FDA 510(k) clearance for the Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)). Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Allmed Medical (Hubei) Protective Products Co., Ltd. (Zhijiang, CN). The FDA issued a Cleared decision on August 12, 2022 after a review of 128 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 K221027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2022
Decision Date August 12, 2022
Days to Decision 128 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
1d faster than avg
Panel avg: 129d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 25
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K221027.
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Surgical Isolation Cover Gown
K220528 · Wuhan Dymex Healthcare Co., Ltd. · Jun 2022
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K213832 · Hubei Xinxin Non-Woven Co., Ltd. · May 2022
Disposable Surgical Isolation Gown
K212422 · Crown Name Disposable Hygiene Products Fty., Ltd. · Apr 2022