FDA.reportPublic FDA data

Texas Medical Technology

Primary DI
00850022960352
Brand
Texas Medical Technology
Company
Texas Medical Technology Inc
Model
GWS-03-XXL-B
Catalog number
GWS-03-XXL-B
Device description
Level 3 Disposable Surgical Gown, XXLarge, Blue
Published
2021-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K120192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120192000DISPOSABLE SURGICAL GOWNSWeihai Hongyu Nonwoven Fabric Products Co., Ltd.2012-10-16FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022960352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022960352008500229603528500229603520850022960352

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment made of natural and/or synthetic materials intended to be worn 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
346.351.9009Omri.Shafran@texasmedicalcentersupply.com

Regulatory Flags#

DUNS number
117479714
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
00850032920568Texas Medical Technology3PLY-PRCMSK-043PLY-PRCMSK-042022-05-02
00850032920483Texas Medical TechnologyGWL-04-SMS-SGWL-04-SMS-S2021-12-16
00850032920490Texas Medical TechnologyGWL-04-SMS-MGWL-04-SMS-M2021-12-16
00850032920506Texas Medical TechnologyGWL-04-SMS-LGWL-04-SMS-L2021-12-16
00850032920513Texas Medical TechnologyGWL-04-SMS-XLGWL-04-SMS-XL2021-12-16
00850032920520Texas Medical TechnologyGWL-04-SMS-2XLGWL-04-SMS-2XL2021-12-16
00850032920452Texas Medical TechnologyGWS-03-3XL-BGWS-03-3XL-B2021-10-28
00850032920469Texas Medical TechnologyGWS-03-4XL-BGWS-03-4XL-B2021-10-28
00850032920476Texas Medical TechnologyGWS-03-5XL-BGWS-03-5XL-B2021-10-28
00850022960321Texas Medical TechnologyGWS-03-M-BGWS-03-M-B2021-02-16
00850022960338Texas Medical TechnologyGWS-03-L-BGWS-03-L-B2021-02-16
00850022960345Texas Medical TechnologyGWS-03-XL-BGWS-03-XL-B2021-02-16
00850022960369Texas Medical TechnologyGWS-03-S-BGWS-03-S-B2021-02-16

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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09009607822221ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
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