FDA.reportPublic FDA data

FlexGard

Primary DI
00860010353257
Brand
FlexGard
Company
LDI Solutions, LLC
Model
CRG-S3XL-MTF
Device description
Cut resistant glove liners, sterile, size 3X-large. (Packaged 10 pair/box. Invoiced by pair.)
Published
2024-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K190782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190782000FlexGard Cut-Resistant Glove LinersLdi Corporation2019-06-27KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010353257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010353257008600103532578600103532570860010353257

GMDN Terms#

Term, Definition table
TermDefinition
Glove linerA cloth glove intended to be worn as a liner underneath rubber, plastic, or latex gloves (examination or surgical) to minimize the risk of allergic reactions, rashes, and other skin irritations, or to reduce the risk of sharps injuries. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
175311088
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010353271EnviroSorb® CommodeShield™ESCS-2824ESCS-28242025-03-04
00860010353288EnviroSorb® CommodeShield™ESCS-3524ESCS-35242025-03-04
00860010353264EnviroSorb® CommodeShield™ESCS-2424ESCS-24242025-03-03
00860010353202FlexGardCRG-SS-MTFCRG-MTF-SS2024-04-11
00860010353219FlexGardCRG-M-MTFCRG-MTF-MTF2024-04-11
00860010353226FlexGardCRG-SL-MTFCRG-SL-MTF2024-04-11
00860010353233FlexGardCRG-SXL-MTF2024-04-11
00860010353240FlexGardCRG-S2XL-MTF2024-04-11

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Primary DI, Brand, Company table
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