Jointown

Primary DI
00810139475675
Brand
Jointown
Company
U.S. HEALTH EXPRESS CORP.
Model
2243
Device description
Jointown Biodegradable Nitrile Exam Glove Large size100 per box10 boxes per case
Published
2025-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223437000Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)Hartalega NGC Sdn. Bhd.2023-05-17LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810139475828PackageGS110In Commercial Distribution
00810139475675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810139475828008101394758288101394758280810139475828
00810139475675008101394756758101394756750810139475675

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.

Regulatory Flags#

DUNS number
081037169
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810139475699Jointown22412025-05-19
00810139475705Jointown22422025-05-19
00810139475828Jointown22432025-05-19
00810139475682Jointown22442025-05-19
00810139475804Jointown22412025-05-19
00810139475811Jointown22422025-05-19
00810139475781Jointown22402025-05-19
00810139472049Jointown22132025-05-06
00810139473015Jointown22132025-05-06
00810139472056Jointown22142025-05-06
00810139473053Jointown22122025-05-06
00810139473091Jointown22112025-05-06
00850017230002Jointown2082Blue20822020-03-18
00850017230026Jointown2082Blue20822020-03-18

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