FDA.reportPublic FDA data

PU YUAN

Primary DI
06921825703690
Brand
PU YUAN
Company
Guangzhou Fuzelong Hygiene Material Co., Ltd.
Model
Surgical Gown
Device description
Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from thetransfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgicalgown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is singleuse, disposable medical devices, provided sterile.
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FYAGown, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222403000Surgical GownGuangzhou Fuzelong Hygiene Material Co., Ltd.2023-01-26FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16921825701044PackageGS120In Commercial Distribution
06921825703690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692182570104416921825701044
06921825703690069218257036906921825703690

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Regulatory Flags#

DUNS number
546983737
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06921825703560PU YUANEar-loops2026-04-29
06921825703577PU YUANEar-loops2026-04-29
06921825703584PU YUANEar-loops2026-04-29
06921825703591PU YUANEar-loops2026-04-29
06921825703607PU YUANTie-on type2026-04-29
06921825703614PU YUANTie-on type2026-04-29
06921825703621PU YUANTie-on type2026-04-29
06921825703638PU YUANSurgical Gown2026-04-29
06921825703645PU YUANSurgical Gown2026-04-29
06921825703652PU YUANSurgical Gown2026-04-29
06921825703669PU YUANSurgical Gown2026-04-29
06921825703683PU YUANSurgical Gown2026-04-29
06921825703706PU YUANTie-on type2026-04-29
06921825701443PU YUANSB2F-HoodGown-XL-EL-M-FP2025-07-05
06921825701450PU YUANMC-0202L2025-07-10
06921825701474PU YUANSB2F-HOOD-M2025-07-21
06921825701481PU YUANSB2F-HoodGown-XL-EL-M-FP2025-07-21
06921825700781PU YUANSB2F-PEELAWAY2024-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
09009607822207ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822214ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822221ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832206ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832213ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832220ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
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