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FDA 510(k)

High Protection Surgical Gown

K-Number: K222456 · 2023-03-12

Applicant3A Medical Products Co., Ltd.
Decision Date2023-03-12
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

High Protection Surgical Gown is a medical device manufactured by 3A Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2023-03-12 under approval number K222456. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the High Protection Surgical Gown?

High Protection Surgical Gown is a medical device that received FDA 510(k) clearance on 2023-03-12. It is manufactured by 3A Medical Products Co., Ltd.. The 510(k) number is K222456.

When was High Protection Surgical Gown approved by the FDA?

High Protection Surgical Gown received FDA 510(k) clearance on 2023-03-12, under approval number K222456.

What company makes High Protection Surgical Gown?

High Protection Surgical Gown is manufactured by 3A Medical Products Co., Ltd..

What is the FDA product code for High Protection Surgical Gown?

The FDA product code for High Protection Surgical Gown is FYA.

Related Clinical Trials

NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT07574164 Closed-loop TMS for Tremor RECRUITING NCT07116668 SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study ENROLLING_BY_INVITATION

Other Devices by 3A Medical Products Co., Ltd.

K2025983 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.

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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