FDA.reportPublic FDA data

Target Up&Up

Primary DI
00850056441209
Brand
Target Up&Up
Company
Armbrust Inc.
Model
GLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X50-M
Device description
USA Made Nitrile Gloves - Blue - Medium - Box of 50
Published
2024-12-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00850056441209PrimaryGS10
85005644120900Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056441209008500564412098500564412090850056441209
8500564412090085005644120900

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

Regulatory Flags#

DUNS number
117532009
Device count
50
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056441247Target Up&UpGLOVE-ARMBRUST-3.2MIL-BLUE-BOX-1X50-M2026-02-05
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
00850056441056ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X90-XXL2025-09-24
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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09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
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08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
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08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12