FDA.reportPublic FDA data

UltraSOFT™ 5000

Primary DI
00860012237234
Brand
UltraSOFT™ 5000
Company
ALKALI SCIENTIFIC, LLC
Model
NG2220
Catalog number
NG2220
Device description
Nitrile Powder Free Medical Exam Gloves, 300/BX, L, 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
Rx
false
OTC
false
Sterile
false
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
00860012237234PackageGS110In Commercial Distribution
00860012237289PrimaryGS10
00198168761434Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012237234008600122372348600122372340860012237234
00860012237289008600122372898600122372890860012237289
00198168761434001981687614341981687614340198168761434

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078363669
Device count
300
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00860012237272UltraSOFT™ 5000NG2215NG22152024-06-12
00860012237289UltraSOFT™ 5000NG2220NG22202024-06-12
00860012237296UltraSOFT™ 5000NG2225NG22252024-06-12
00860012237203UltraSOFT™ 5000NG2205NG22052024-06-12
00860012237210UltraSOFT™ 5000NG2210NG22102024-06-12
00860012237227UltraSOFT™ 5000NG2215NG22152024-06-12
00198168199145UltraSOFT™ 5000NG2225NG22252024-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06