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FDA 510(k)

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue

K-Number: K212633 · 2021-11-24

ApplicantString King Lacrosse, LLC
Decision Date2021-11-24
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue is a medical device manufactured by String King Lacrosse, LLC. It received FDA 510(k) clearance on 2021-11-24 under approval number K212633. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue?

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by String King Lacrosse, LLC. The 510(k) number is K212633.

When was Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue approved by the FDA?

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue received FDA 510(k) clearance on 2021-11-24, under approval number K212633.

What company makes Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue?

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue is manufactured by String King Lacrosse, LLC.

What is the FDA product code for Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue?

The FDA product code for Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue is FYC.

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Other Devices by String King Lacrosse, LLC

K202607Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs

Related Devices (Code: FYC)

K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Primed Medical Products, Inc. K160339Cardinal Health Isolation GownCardinal Health200, LLC K160471Medline Non-Surgical Isolation Gown-Medline Industries, Inc. K171535SURGICAL ISOLATION GOWNJingzhou Haixin Green Cross Medical Products Co., Ltd. K190306AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. K211538Protect X Level 3 Isolation GownAzac Group

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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