FDA.reportPublic FDA data

UltraCruz - Nitrile Plus

Primary DI
00810500026864
Brand
UltraCruz - Nitrile Plus
Company
Santa Cruz Biotechnology, Inc.
Model
SC-359594
Catalog number
SC-359594
Device description
UltraCruz Nitrile Plus Exam Gloves, Powder Free, Small 100 X 10
Published
2022-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10810500026861PackageGS110In Commercial Distribution
00810500026864PrimaryGS10
70810500026863Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081050002686110810500026861
00810500026864008105000268648105000268640810500026864
7081050002686370810500026863

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
8004573801aldrichm@scbt.com

Regulatory Flags#

DUNS number
782655427
Device count
100
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810500021357UltraCruz - Nitrile PlusSC-359592SC-3595922022-07-18
00810500026901UltraCruz - Nitrile PlusSC-359596SC-3595962022-07-18
00810500026925UltraCruz - Nitrile PlusSC-359598SC-3595982022-07-18
00810500026949UltraCruz - Nitrile PlusSC-359600SC-3596002022-07-18
10810500021354UltraCruz - Nitrile PlusSC-359592SC-3595922022-07-18
10810500026861UltraCruz - Nitrile PlusSC-359594SC-3595942022-07-18
10810500026908UltraCruz - Nitrile PlusSC-359596SC-3595962022-07-18
10810500026922UltraCruz - Nitrile PlusSC-359598SC-3595982022-07-18
10810500026946UltraCruz - Nitrile PlusSC-359600SC-3596002022-07-18

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