FDA.reportPublic FDA data

NitriTech Ultra

Primary DI
00850042054376
Brand
NitriTech Ultra
Company
SUMMIT GLOVE INC.
Model
61050PF-XL
Device description
"6mil, 12"" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish, Single Use, Beaded Cuff, Blue, Size X-Large"
Published
2022-12-12
Public version status
New
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
01500420543761PackageGS11000In Commercial Distribution
00850018374361PreviousGS10
00850042054376PrimaryGS10
00850042054383Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01500420543761015004205437611500420543761
00850018374361008500183743618500183743610850018374361
00850042054376008500420543768500420543760850042054376
00850042054383008500420543838500420543830850042054383

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
3308680066tcalkins@summitglove.com

Regulatory Flags#

DUNS number
054386458
Device count
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018374101AmbiNitrile570-BL-72020-08-01
00850018374125AmbiNitrile570-BL-82020-08-01
00850018374149AmbiNitrile570-BL-92020-08-01
00850018374163AmbiNitrile570-BL-102020-08-01
00850018374187AmbiNitrile570-BL-112020-08-01
00850018374200AmbiNitrile570-GR-72020-08-01
00850018374224AmbiNitrile570-GR-82020-08-01
00850018374248AmbiNitrile570-GR-92020-08-01
00850018374262AmbiNitrile570-GR-102020-08-01
00850018374286AmbiNitrile570-GR-112020-08-01
00850018374620NitriTech76720PF-S2020-08-01
00850018374644NitriTech76730PF-M2020-08-01
00850018374668NitriTech76740PF-L2020-08-01
00850018374682NitriTech76750PF-XL2020-08-01
00850018374705NitriTech76760PF-2XL2020-08-01
00850018374729NitriTech76770PF-3XL2020-08-01
00850019992083ResQ-Grip79720PF-BKGR2020-08-01
00850019992106ResQ-Grip79730PF-BKGR2020-08-01
00850019992120ResQ-Grip79740PF-BKGR2020-08-01
00850019992144ResQ-Grip79750PF-BKGR2020-08-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
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08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
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20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
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20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
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10840330702239ProCureTwin Med, LLCLZA2026-06-01