FDA.reportPublic FDA data

NitriTech Ultra

Primary DI
00850020255986
Brand
NitriTech Ultra
Company
SUMMIT GLOVE INC.
Model
61040PF-L
Device description
"6mil, 12"" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish, Single Use, Beaded Cuff, Blue, Size 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
01500202559867PackageGS11000In Commercial Distribution
00850018374347PreviousGS10
00850020255986PrimaryGS10
00850020255993Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01500202559867015002025598671500202559867
00850018374347008500183743478500183743470850018374347
00850020255986008500202559868500202559860850020255986
00850020255993008500202559938500202559930850020255993

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01