Specfit

Primary DI
00196852240364
Brand
Specfit
Company
Vallen Distribution, Inc.
Model
DN4MBXL
Device description
Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, XL
Published
2023-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121526000POWER-FREE NITRILE PATIENT EXAMINATION GLOVESShandong Junchi Medical Products Co., Ltd.2012-08-03LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196852240364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196852240364001968522403641968522403640196852240364

GMDN Terms#

Term, Definition table
TermDefinition
Utility gloveA hand-worn device intended to be used by healthcare personnel to protect the hands from contamination and/or injury during paraclinical/non-clinical activities (e.g., handling waste, instrument reprocessing). It may be available in a variety of forms or with specific attributes (e.g., rubber, reinforced, heat resistant, with extended sleeve), however is not intended to protect from extreme cold/cryogenic temperatures (i.e., not a cryogenic safety glove). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.25Millimeter
Length8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
782807804
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196852445684SpecfitDN4MBS2023-09-29
00196852902323SpecfitDN4MBL2023-09-29
00196852952410SpecfitDN4MBM2023-09-29

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