FDA.reportPublic FDA data

Tronex International, Inc.

Primary DI
00097604909945
Brand
Tronex International, Inc.
Company
TRONEX INTERNATIONAL, INC.
Model
9099-35
Device description
Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, 12", Powder-Free, Latex-Free, Blue, Extra-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

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10097604909942PrimaryGS10
00097604909945Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1009760490994210097604909942
00097604909945000976049099450976049099450097604909945

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.

Sterilization Methods#

Method table
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975219206298RhesusZibo Blue Sail Innovation Co., Ltd.LZA2026-05-26
06975913080118ShengkunZibo Shengkun Chemical Industry Co., Ltd.LZA2026-05-26
00860015678935UCKER1ST TRY, CORPLZA2026-05-22
00860015678959UCKER1ST TRY, CORPLZA2026-05-22
00860015678966UCKER1ST TRY, CORPLZA2026-05-22
00860015678973UCKER1ST TRY, CORPLZA2026-05-22
10194346659194EquateWAL-MART STORES, INC.LZA2026-03-24
10194346659200EquateWAL-MART STORES, INC.LZA2026-03-24
00850006162215Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162192Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162222Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162239Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162246Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162185Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162178Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162161Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162154Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162147Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162130Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162352Posi-Prene Edge PinkClinical Supply CompanyLZA2026-03-24
00850006162369Posi-Prene Edge PinkClinical Supply CompanyLZA2026-03-24
00850006162376Posi-Prene Edge PinkClinical Supply CompanyLZA2026-03-24
00850006162345Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162321Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162314Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162307Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162048Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162031Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162024Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162017Posi-Prene GreenClinical Supply CompanyLZA2026-03-24