FDA.reportPublic FDA data

YADU

Primary DI
06979247712035
Brand
YADU
Company
YADU Medical (Henan) Co., Ltd.
Model
Standard--XL
Device description
"Level 3 Surgical Gown (Standard & Reinforced) are sterile, single-use surgical apparel intended tobe worn by healthcare professionals during surgical procedures to provide barrier protection againstthe transfer of microorganisms, body fluids, and particulate matter in critical surgical zones for bothpatients and healthcare personnel.The products meet the respective liquid barrier performance requirements for Level 3 as specified inANSI/AAMI PB70:2022 ""Liquid barrier performance and classification of protective apparel anddrapes intended for use in health care facilities""."
Published
2026-05-17
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
K250564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250564000Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.2025-12-03FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06979247712035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979247712035069792477120356979247712035

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
542078504
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979247710765YADUSY0255 Reinforced--S2026-05-17
06979247710772YADUSY0256 Reinforced--M2026-05-17
06979247710789YADUSY0257 Reinforced--L2026-05-17
06979247710796YADUSY0258 Reinforced--XL2026-05-17
06979247710802YADUSY0259 Reinforced--XXL2026-05-17
06979247710819YADUSY0260 Reinforced--XXXL2026-05-17
06979247712004YADUStandard--S2026-05-17
06979247712011YADUStandard--M2026-05-17
06979247712028YADUStandard--L2026-05-17
06979247712042YADUStandard--XXL2026-05-17
06979247712059YADUStandard--XXXL2026-05-17
06979247712066YADUReinforced--S2026-05-17
06979247712073YADUReinforced--M2026-05-17
06979247712080YADUReinforced--L2026-05-17
06979247712097YADUReinforced--XL2026-05-17
06979247712103YADUReinforced--XXL2026-05-17
06979247712110YADUReinforced--XXXL2026-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
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
20888277720050MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-11
20888277419879MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277419886MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277660905MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674704MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674711MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674728MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674735MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
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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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