FDA.reportPublic FDA data

UltraSOFT™ 5000

Primary DI
00860012237272
Brand
UltraSOFT™ 5000
Company
ALKALI SCIENTIFIC, LLC
Model
NG2215
Catalog number
NG2215
Device description
Nitrile Powder Free Medical Exam Gloves, 300/BX, M, Tested for Use with Chemotherapy Drugs
Published
2024-06-12
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
00860012237227PackageGS110In Commercial Distribution
00860012237272PrimaryGS10
00198168300572Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012237227008600122372278600122372270860012237227
00860012237272008600122372728600122372720860012237272
00198168300572001981683005721981683005720198168300572

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
300
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
00810213480298UltraSOFT™ 1000NG1125NG11252026-01-05
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
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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10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
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00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
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00850005229612NeuflexMedgluv Inc.LZA2026-06-29
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10304040194048EssentialsHENRY SCHEIN, INC.LZA2026-06-25
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10304040194079EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194086EssentialsHENRY SCHEIN, INC.LZA2026-06-25
00050428426777CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLZA2026-06-24