FDA.reportPublic FDA data

Black Talon

Primary DI
00842209133277
Brand
Black Talon
Company
NORTH AMERICAN RESCUE, LLC
Model
70-0001
Catalog number
70-0001
Device description
GLOVES, BLACK NITRILE - SMALL (Box of 100)
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232654000Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)Nephron Nitrile, LLC2024-03-20LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30842209133278PackageGS110In Commercial Distribution
00842209133277PrimaryGS10
10842209133274Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084220913327830842209133278
00842209133277008422091332778422091332770842209133277
1084220913327410842209133274

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile surgical glove, non-powderedA sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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
832426782
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842209112098NAR30-000630-00062022-11-15
00842209139255NAR Kit10-010310-01032026-07-06
00842209139262NAR85-515685-51562026-07-06
00842209139279NAR85-516985-51692026-07-06
00842209139286NAR80-0159-TLS80-0159-TLS2026-07-06
00842209139293NAR80-146180-14612026-07-06
00842209122691NAR85-12972022-12-08
00842209123926NAR80-09232022-12-08
00842209139149NAR10-000810-00082026-06-22
00842209139156NAR10-000910-00092026-06-22
00842209139163NAR10-001010-00102026-06-22
00842209139170NAR10-001110-00112026-06-22
00842209139187NAR10-001210-00122026-06-22
00842209139194NAR10-001310-00132026-06-22
00842209139200NAR10-001410-00142026-06-22
00842209139231NAR80-156280-15622026-06-22
00842209139248NAR85-515385-51532026-06-22
00842209138760NAR77-014377-01432026-05-27
00842209138777NAR77-014477-01442026-05-27
00842209138784NAR77-014577-01452026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975065506Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065513Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065520Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065537Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
00860010400937LuvatekR&C Imports LLCLZA2026-07-29
10304040195038CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.LZC2026-07-29
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229803NeulynxMedgluv Inc.QDO2026-07-17