FDA.report

Tronex International, Inc.

Primary DI
00097604316637
Brand
Tronex International, Inc.
Company
TRONEX INTERNATIONAL, INC.
Model
3166-30
Device description
Glove, Exam, Latex, Fully Textured, Powder-Free, Natural, Large
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

Related Records

Product Codes

CodeName
LYYLatex Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10097604316634PrimaryGS10
00097604316637Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1009760431663410097604316634
00097604316637000976043166370976043166370097604316637

GMDN Terms

TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
615425519
Device count
1000
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00097604555517Tronex International, Inc.5555W2025-07-28
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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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