FDA.reportPublic FDA data

Trustex

Primary DI
00726893116726
Brand
Trustex
Company
GLOBAL PROTECTION CORP.
Model
TXM04U
Device description
Trustex Nitrile Exam Gloves, Large, box of 100
Published
2024-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
K223214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223214000Powder-Free Nitrile Examination GlovesGlobal Protection Corp.2023-09-21LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20726893116720PackageGS11000In Commercial Distribution
00726893116726PrimaryGS10
80726893116722Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2072689311672020726893116720
00726893116726007268931167267268931167260726893116726
8072689311672280726893116722

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dark, dry place. Avoid excessive heat.

Contacts#

Phone, Email table
PhoneEmail
6179462800ccataldo@globalprotection.com

Regulatory Flags#

DUNS number
364614362
Device count
100
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00726893120365One Lux11320062026-06-08
00726893120594Harmony Latex DamPHA202R2026-06-08
00726893120600harmony Non- Latex damsPHA101U2026-06-08
00726893120617Harmony Latex DamsPHA202U2026-06-08
00726893120730One Lux11330062026-06-08
00726893120747One Lux11340062026-06-08
00726893120778One Unity Collection11600BY2026-06-08
00726893120945One Lux113200B2026-06-08
00726893120952One Lux113300B2026-06-08
00726893120969One Lux113400B2026-06-08
00810124865085Adam and Eve hard rider99PHE200C2026-06-08
00860015576620Swoon Ultra Thin99SWON2022026-06-08
10860015576603Swoon Ultra Thin99SWON200C2026-06-08
00726893120587Harmony non-Latex DamPHA101R2026-06-04
00726893120754TrustexTXD05U2026-06-04
00726893120761Super sensitiveCRDF-62026-06-04
20726893120482Mixed Pleasure110109C2026-06-04
20726893120710Glowing Pleasures11500BC2026-06-04
20726893120574One Super sensitive11600CY2026-04-28
20726893120673One Classic Select11000BYC2026-04-28

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