FDA.reportPublic FDA data

UltraSOFT™ 1000

Primary DI
00810213480298
Brand
UltraSOFT™ 1000
Company
ALKALI SCIENTIFIC, LLC
Model
NG1125
Catalog number
NG1125
Device description
Nitrile Powder Free Medical Exam Gloves, 100/Box, XL, Tested for Use with Chemotherapy Drugs
Published
2026-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00810213480304PackageGS110In Commercial Distribution
00810213480298PrimaryGS10
00810213480281Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810213480304008102134803048102134803040810213480304
00810213480298008102134802988102134802980810213480298
00810213480281008102134802818102134802810810213480281

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.

Regulatory Flags#

DUNS number
078363669
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810213480168UltraSOFT™ 1000NG1105NG11052026-01-05
00810213480199UltraSOFT™ 1000NG1110NG11102026-01-05
00810213480236UltraSOFT™ 1000NG1115NG11152026-01-05
00810213480267UltraSOFT™ 1000NG1120NG11202026-01-05
00810213480175UltraSOFT™ 1000NG1105NG11052026-01-05
00810213480205UltraSOFT™ 1000NG1110NG11102026-01-05
00810213480243UltraSOFT™ 1000NG1115NG11152026-01-05
00810213480250UltraSOFT™ 1000NG1120NG11202026-01-05
00810213480304UltraSOFT™ 1000NG1125NG11252026-01-05
00860012237258UltraSOFT™ 5000NG2205NG22052024-06-12
00860012237265UltraSOFT™ 5000NG2210NG22102024-06-12
00860012237272UltraSOFT™ 5000NG2215NG22152024-06-12
00860012237289UltraSOFT™ 5000NG2220NG22202024-06-12
00860012237296UltraSOFT™ 5000NG2225NG22252024-06-12
00860012237203UltraSOFT™ 5000NG2205NG22052024-06-12
00860012237210UltraSOFT™ 5000NG2210NG22102024-06-12
00860012237227UltraSOFT™ 5000NG2215NG22152024-06-12
00860012237234UltraSOFT™ 5000NG2220NG22202024-06-12
00198168199145UltraSOFT™ 5000NG2225NG22252024-06-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952153NeulynxMedgluv Inc.LZA2026-06-26
10304040194048EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194055EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194062EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194079EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194086EssentialsHENRY SCHEIN, INC.LZA2026-06-25
00050428426777CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLZA2026-06-24
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00840546402315sunnycareAgio Group Inc.LZA2026-06-10
00840546402339sunnycareAgio Group Inc.LZA2026-06-10
00840546402353sunnycareAgio Group Inc.LZA2026-06-10
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00840546402391sunnycareAgio Group Inc.LZA2026-06-10
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
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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