FDA.reportPublic FDA data

MedPride Reinforced Surgical Gowns

Primary DI
10352410702843
Brand
MedPride Reinforced Surgical Gowns
Company
SHIELD-LINE, LLC
Model
70284
Catalog number
70284
Device description
Surgical GownSterileMedium
Published
2018-08-30
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

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
K101593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101593000EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXLExact Medical Manufacturing, Inc.2010-09-03FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10352410702843PrimaryGS10
00352410702846Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035241070284310352410702843
00352410702846003524107028463524107028460352410702846

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

Regulatory Flags#

DUNS number
078518916
Device count
20
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10352410653640MedPrideSilicone TapeMPR-653642022-09-15
10352410516129MedPrideSIZE 6.0MPR-516122021-10-07
10352410516136MedPrideSIZE 6.5MPR-516132021-10-07
10352410516143MedPrideSIZE 7.0MPR-516142021-10-07
10352410516150MedPrideSIZE 7.5MPR-516152021-10-07
10352410516167MedPrideSIZE 8.0MPR-516162021-10-07
10352410516174MedPrideSIZE 8.5MPR-516172021-10-07
00352410516122MedPrideSIZE 6.0MPR-516122021-10-07
00352410516139MedPrideSIZE 6.5MPR-516132021-10-07
00352410516146MedPrideSIZE 7.0MPR-516142021-10-07
00352410516153MedPrideSIZE 7.5MPR-516152021-10-07
00352410516160MedPrideSIZE 8.0MPR-516162021-10-07
00352410516177MedPrideSIZE 8.5MPR-516172021-10-07
10352410652728MedPride65272652722019-08-07
10352410652742MedPride65274MPR-652742019-08-07
10352410652780MedPride65278MPR-652782019-08-07
10352410702874MedPride Reinforced Surgical Gowns 70287702872020-07-08
10352410702850MedPride Reinforced Surgical Gowns 70285702852018-08-31
10352410702867MedPride Reinforced Surgical Gowns 70286702862018-08-31
10352410906111MedPride90611906112017-08-25

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