UltraSOFT™ 1000

Primary DI
00810213480304
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
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
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078363669
Device count
100
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
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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00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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