FDA.reportPublic FDA data

Truline

Primary DI
00850052602451
Brand
Truline
Company
Arbill Industries, Inc.
Model
A155022
Device description
BL China Clear Vinyl, Med
Published
2025-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170735000Powder-Free Clear Vinyl Patient Examination GlovesZibo Yue Fan Medical Products Co, Ltd.2017-06-27LYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850052602451PrimaryGS10
10850052602458Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850052602451008500526024518500526024510850052602451
1085005260245810850052602458

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
014631246
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850052602444TrulineA1550212025-08-12
00850052602468TrulineA1550232025-08-12
00850052602475TrulineA1550242025-08-12
10850052602441TrulineA1550212025-08-12
10850052602458TrulineA1550222025-08-12
10850052602465TrulineA1550232025-08-12
10850052602472TrulineA1550242025-08-12
00850052602277TrulineA1123442025-07-24
10850052602274TrulineA1123442025-07-24
00850052602246TrulineA1123412025-07-23
00850052602253TrulineA1123422025-07-23
00850052602260TrulineA1123432025-07-23
00850052602284TrulineA1123512025-07-23
00850052602291TrulineA1123522025-07-23
00850052602307TrulineA1123532025-07-23
00850052602314TrulineA1123542025-07-23
00850052602321TrulineA1223412025-07-23
00850052602338TrulineA1223422025-07-23
00850052602345TrulineA1223432025-07-23
00850052602352TrulineA1223442025-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27
10840330701959ProCureTwin Med, LLCLYZ2026-05-27
10840330701966ProCureTwin Med, LLCLYZ2026-05-27
10840330701973ProCureTwin Med, LLCLYZ2026-05-27
10840330701980ProCureTwin Med, LLCLYZ2026-05-27
10840330701997ProCureTwin Med, LLCLYZ2026-05-27
10840330702253ProCureTwin Med, LLCLYZ2026-05-27
10840330702260ProCureTwin Med, LLCLYZ2026-05-27
10840330702277ProCureTwin Med, LLCLYZ2026-05-27
10840330702284ProCureTwin Med, LLCLYZ2026-05-27
10840330705162ProCureTwin Med, LLCLYZ2026-05-27
10840330705179ProCureTwin Med, LLCLYZ2026-05-27
10840330705186ProCureTwin Med, LLCLYZ2026-05-27
10840330705193ProCureTwin Med, LLCLYZ2026-05-27
10840330705209ProCureTwin Med, LLCLYZ2026-05-27
10840330705216ProCureTwin Med, LLCLYZ2026-05-27
10840330705223ProCureTwin Med, LLCLYZ2026-05-27
10840330705230ProCureTwin Med, LLCLYZ2026-05-27
20193489081562MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081586MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
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10889483584446AirLife™AIRLIFELYZ2025-02-14
20197344098184SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-27
20197344098160SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098177SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098191SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
10860011916618Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19