FDA.reportPublic FDA data

Disposable ultra Reinforced Surgical Gown

Primary DI
06971604530306
Brand
Disposable ultra Reinforced Surgical Gown
Company
Hubei Medlink Healthcare Co.,Ltd
Model
MSG068
Catalog number
MSG068
Device description
Surgical Gowns
Published
2021-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K173847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173847000Disposable Ultra Reinforced Surgical GownXiantao Rayxin Medical Products Co., Ltd.2019-01-16FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971604530306PackageGS150In Commercial Distribution
16971604530006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971604530306069716045303066971604530306
1697160453000616971604530006

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8737387582lynn.w@medlinkindustry.com

Regulatory Flags#

DUNS number
544376822
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16971604530006Disposable ultra Reinforced Surgical GownMSG068MSG0682021-04-08
16971604530020Disposable ultra Reinforced Surgical GownMSG068MSG0682021-04-08
16971604530044Disposable Ultra Reinforced Surgical GownMSG068MSG0682021-04-08
16971604530013Disposable Ultra Reinforced Surgical GownMSG068MSG0682021-04-08
06971604530283Disposable ultra Reinforced Surgical GownMSG068MSG0682021-04-08
06971604530276Disposable Ultra Reinforced Surgical GownMSG068MSG0682021-04-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
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20888277674711MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674728MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
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