FDA.reportPublic FDA data

Tronex International, Inc.

Primary DI
00097604878715
Brand
Tronex International, Inc.
Company
TRONEX INTERNATIONAL, INC.
Model
8787-10
Device description
Glove, Exam, Synthetic Vinyl, SynTech, Powder-Free, Latex-Free, Natural, Small
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10097604878712PrimaryGS10
00097604878715Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1009760487871210097604878712
00097604878715000976048787150976048787150097604878715

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
615425519
Device count
1700
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00097604555517Tronex International, Inc.5555W2025-07-28
00097604577021Tronex International, Inc.577025W2025-07-24
00097604577045Tronex International, Inc.577035W2025-07-24
00097604130585Tronex International, Inc.TCB0305C2025-05-01
00097604140584Tronex International, Inc.TCB0405C2025-05-01
00097604160582Tronex International, Inc.TCB0605C2025-05-01
00097604220583Tronex International, Inc.TLB2205L2025-05-01
00097604330589Tronex International, Inc.TLB3305L2025-05-01
00097604440585Tronex International, Inc.TLB4405L2025-05-01
00097604660587Tronex International, Inc.TLB6605L2025-05-01
00097604015561Tronex International, Inc.TCB0155R2025-01-28
00097604010580Tronex International, Inc.TCB0105C2024-12-30
00097604020589Tronex International, Inc.TCB0205C2024-12-30
00097604110587Tronex International, Inc.TCB1105A2024-12-30
00097604120586Tronex International, Inc.TCB1205A2024-12-30
00097604212199Tronex International, Inc.SD21212024-12-30
00097604215190Tronex International, Inc.SD21512024-12-30
00097604313193Tronex International, Inc.SD31312024-12-30
00097604422291Tronex International, Inc.TCB4222N2024-12-30
00097604423397Tronex International, Inc.TCB4233N2024-12-30

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Primary DI, Brand, Company table
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