FDA.reportPublic FDA data

HALYARD

Primary DI
26931918166299
Brand
HALYARD
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
47283-81
Device description
Valueselect*High Performance Surgical Gown_L_X-Long_with Reinforced_Non-sterile_420ea/cs
Published
2025-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K102652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102652000NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNSGri Medical & Electronic Technology Co., Ltd.2011-02-03FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918166299PackageGS11In Commercial Distribution
36931918166296PackageGS1420In Commercial Distribution
16931918166292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191816629926931918166299
3693191816629636931918166296
1693191816629216931918166292

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
+86057383617385link_dong@gri-china.com

Regulatory Flags#

DUNS number
679894738
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16931918100876Alleset80-01306T2026-06-04
16931918102450Alleset001-CAM0796PS2026-06-04
16931918104201Alleset001-BND0022S2026-06-04
16931918104416Alleset001-BND3636S2026-06-04
16931918104645Alleset80-01305T2026-06-04
16931918104843Alleset001-CARM24S2026-06-04
16931918104935Alleset001-BND3020S2026-06-04
16931918105239Alleset001-BND0018S2026-06-04
16931918106977Alleset001-CARM9S2026-06-04
16931918107400Alleset001-BND3620S2026-06-04
16931918107929Alleset001-CAM0796EVS2026-06-04
16931918108261Alleset001-BND0014S2026-06-04
16931918109640Alleset001-CAM0996ES2026-06-04
16931918109855Alleset001-CAM0796ES2026-06-04
16931918109879Alleset001-BND3630S2026-06-04
16931918117102Alleset001-BND3640S2026-06-04
16931918119823Alleset50-LFT0012026-06-04
16931918123325Alleset90-8030ST2026-06-04
16931918139449Alleset001-CARM2S2026-06-04
16931918179179Alleset80-01304T2026-06-04

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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09009607832206ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
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09009607832220ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
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