FDA.reportPublic FDA data

MedPride

Primary DI
10352410516150
Brand
MedPride
Company
SHIELD-LINE, LLC
Model
SIZE 7.5
Catalog number
MPR-51615
Device description
Intended to be used in surgery for patients and user
Published
2021-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122557000MOTEX POWDER-FREE NITRILE SURGICAL GLOVESShanghai Motex Healthcare Co., Ltd.2013-10-03KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10352410516150PrimaryGS10
00352410516153Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035241051615010352410516150
00352410516153003524105161533524105161530352410516153

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile surgical glove, non-powderedA sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
078518916
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
10352410702843MedPride Reinforced Surgical Gowns 70284702842018-08-30
10352410702850MedPride Reinforced Surgical Gowns 70285702852018-08-31
10352410702867MedPride Reinforced Surgical Gowns 70286702862018-08-31
10352410906111MedPride90611906112017-08-25

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Primary DI, Brand, Company table
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