FDA.reportPublic FDA data

Vinyl Powder Free Vinyl Examination Gloves

Primary DI
D89260705511310
Brand
Vinyl Powder Free Vinyl Examination Gloves
Company
MAXILL, INC.
Model
6070551131
Published
2022-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D89260705511311PrimaryHIBCC0
D89260705511312PrimaryHIBCC0
D89260705511310Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079343581
Device count
1000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D89260705600570AUTOCLAVE TAPE60705600572022-09-19
D89260705600580AUTOCLAVE TAPE60705600582022-09-19
D89260705600590AUTOCLAVE TAPE60705600592022-09-19
00060705811240u-test SI Steam Sterilization Integrator811242016-10-17
D89260705533181POLYALL CURING LIGHT SLEEVE60705533182022-07-22
D89260705533182POLYALL CURING LIGHT SLEEVE60705533182022-07-22
D89260705533191POLYALL CURING LIGHT SLEEVE60705533192022-07-22
D89260705533192POLYALL CURING LIGHT SLEEVE60705533192022-07-22
D89260705535201COVERMAX OPTIMUM HEADREST COVER60705535202022-10-20
D8926070553525BU1COVERMAX OPTIMUM HEADREST COVER6070553525BU2022-10-20
D8926070553525GN1COVERMAX OPTIMUM HEADREST COVER6070553525GN2022-10-20
D8926070553525LV1COVERMAX OPTIMUM HEADREST COVER6070553525LV2022-10-20
D89260705533601PHOSPHOR PLATE BARRIER ENVELOPES60705533602022-07-22
D89260705533602PHOSPHOR PLATE BARRIER ENVELOPES60705533602022-07-22
D89260705533611PHOSPHOR PLATE BARRIER ENVELOPES60705533612022-07-22
D89260705533612PHOSPHOR PLATE BARRIER ENVELOPES60705533612022-07-22
D89260705533621PHOSPHOR PLATE BARRIER ENVELOPES60705533622022-07-22
D89260705533622PHOSPHOR PLATE BARRIER ENVELOPES60705533622022-07-22
D89260705533651PHOSPHOR PLATE BARRIER ENVELOPES60705533652022-07-22
D89260705533652PHOSPHOR PLATE BARRIER ENVELOPES60705533652022-07-22

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