Cleared Traditional

K212633 - Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue (FDA 510(k) Clearance)

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

K212633 · String King Lacrosse, LLC · General Hospital
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Nov 2021
Decision
97d
Days
Class 2
Risk

K212633 is an FDA 510(k) clearance for the Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - .... Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by String King Lacrosse, LLC (Gardena, US). The FDA issued a Cleared decision on November 24, 2021 after a review of 97 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 String King Lacrosse, LLC devices

Submission Details

510(k) Number K212633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2021
Decision Date November 24, 2021
Days to Decision 97 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
31d faster than avg
Panel avg: 128d · This submission: 97d
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

Medical Device Academy, Inc.
Sharon Morrow

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 67
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K212633.
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
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Copioumed Chemotherapy Isolation Gown
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Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223411 · Xiamen Probtain Medical Techology Co., Ltd. · Jan 2023
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K212717 · Paneffort, LLC · Nov 2022