FDA.reportPublic FDA data

Armbrust

Primary DI
00850056441056
Brand
Armbrust
Company
Armbrust Inc.
Model
GLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X90-XXL
Device description
USA Made Nitrile Gloves - Blue - Extra Extra Large - Box of 90
Published
2025-09-24
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
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222898000SafeSource Direct Blue Powder-Free Nitrile Exam GlovesSafesource Direct, LLC2022-11-07LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056441056PrimaryGS10
85005644105600Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056441056008500564410568500564410560850056441056
8500564410560085005644105600

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.
Storage Environment Temperature60 Degrees Fahrenheit80 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
512-807-0744support@armbrust.com

Regulatory Flags#

DUNS number
117532009
Device count
90
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
85005644124700Target Up&UpGLOVE-ARMBRUST-3.2MIL-BLUE-BOX-1X50-M2026-02-05
00850056441001ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-XS2025-09-24
00850056441018ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-S2025-09-24
00850056441025ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-M2025-09-24
00850056441032ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-l2025-09-24
00850056441049ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-XL2025-09-24
85005644100100ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-XS2025-09-24
85005644101800ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-S2025-09-24
85005644102500ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-M2025-09-24
85005644103200ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-l2025-09-24
85005644104900ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-XL2025-09-24
85005644105600ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X90-XXL2025-09-24
10850056441206Target Up&UpGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X50-M2024-12-27
008500225500033-Ply Disposable Surgical Face Masks8500225500032023-01-27
00850022550218Fold Flat Surgical Mask8500225502182023-01-27
00850022550249American Kid Disposable Face Maks8500225502492023-01-27

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Primary DI, Brand, Company table
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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
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10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
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10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZC2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZC2026-07-14
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