FDA.report

FlexGard

Primary DI
00860010353240
Brand
FlexGard
Company
LDI Solutions, LLC
Model
CRG-S2XL-MTF
Device description
Cut resistant glove liners, sterile, size 2X-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
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KGOSurgeon'S Gloves

Product Code Classifications

CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions

SubmissionSupplement
K190782000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K190782000FlexGard Cut-Resistant Glove LinersLdi Corporation2019-06-27KGO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860010353240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010353240008600103532408600103532400860010353240

GMDN Terms

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

Regulatory Flags

DUNS number
175311088
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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
00860010353257FlexGardCRG-S3XL-MTF2024-04-11

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