FDA.reportPublic FDA data

Miracle

Primary DI
00653195671687
Brand
Miracle
Company
ADENNA LLC
Model
MIR168
Catalog number
MIR168
Device description
MIRACLE® Disposable Nitrile Exam Gloves, Powder Free, Blue, 3.5 mil, Ex-Large, 180/bx, 10 bxs/cs
Published
2020-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653195671684PackageGS110In Commercial Distribution
00653195671687PrimaryGS10
70653195671686Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065319567168410653195671684
00653195671687006531956716876531956716870653195671687
7065319567168670653195671686

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide 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.

Contacts#

Phone, Email table
PhoneEmail
8003219832info@hospeco.com

Regulatory Flags#

DUNS number
112042723
Device count
180

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653195737703PrecisionPCS770PCS7702020-04-20
00653195737727PrecisionPCS772PCS7722020-04-20
00653195737758PrecisionPCS775PCS7752020-04-20
00653195737765PrecisionPCS776PCS7762020-04-20
00653195737789PrecisionPCS778PCS7782020-04-20
00653195002207Night AngelNGL220NGL2202020-04-22
00653195002221AdennaNGL222NGL2222020-04-20
00653195002252Night AngelNGL225NGL2252020-04-20
00653195002269Night AngelNGL226NGL2262020-04-17
00653195002283Night AngelNGL228NGL2282020-04-20
00653195002306AdennaVPF230VPF2302020-04-20
00653195002320AdennaVPF232VPF2322020-04-20
00653195002351AdennaVPF235VPF2352020-04-20
00653195002368AdennaVPF236VPF2362020-04-20
00653195002382AdennaVPF238VPF2382020-04-20
00653195002603AdennaGLD260GLD2602020-04-17
00653195002627AdennaGLD262GLD2622020-04-17
00653195002658AdennaGLD265GLD2652020-04-17
00653195002665AdennaGLD266GLD2662020-04-17
00653195002689AdennaGLD268GLD2682020-04-17

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Primary DI, Brand, Company table
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