Cleared Traditional

Amerishield Surgical Mask (K211520) - FDA 510(k) Clearance

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

K211520 · Premiumestore, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
29d
Days
Class 2
Risk

K211520 is an FDA 510(k) clearance for the Amerishield Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Premiumestore, LLC (Virginia Beach, US). The FDA issued a Cleared decision on June 15, 2021 after a review of 29 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 Premiumestore, LLC devices

Submission Details

510(k) Number K211520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2021
Decision Date June 15, 2021
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code FXX Mask, 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

Regulatory Technology Services, LLC
Prithul Bom

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 - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K211520.
Nordiwell Surprotect Face Mask
K210445 · Changzhou Combat Protective Equipment Co., Ltd. · Jun 2021
Disposable Surgical Mask
K210840 · Safeway Industry Healthcare. · Jun 2021
Disposable Medical Surgical Face Mask
K203200 · Guangdong Haiou Medical Apparatus Co., Ltd. · Jun 2021
Surgical Face Mask
K210518 · Shandong Haidike Medical Products Co., Ltd. · Jun 2021
Medical Face Mask
K202714 · Chongqing Chaoke Industry Development Co., Ltd. · Jun 2021
Surgical Face Mask
K203732 · Zhuhai Gaoge Medical Technology Co., Ltd. · Jun 2021

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.