FDA.reportPublic FDA data

Huckleberry

Primary DI
00850045437640
Brand
Huckleberry
Company
Nephron Nitrile LLC
Model
200104004
Device description
Huckleberry Nitrile Powder-free Examination Polymer Coated Chemo & Fentanyl Tested Fingertip Textured Blue L
Published
2024-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K231349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231349000Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)Nephron Nitrile, LLC2023-06-06LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850045437644PackageGS110In Commercial Distribution
30850045437641PackageGS11In Commercial Distribution
00850045437640PrimaryGS10
10850045437647Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085004543764420850045437644
3085004543764130850045437641
00850045437640008500454376408500454376400850045437640
1085004543764710850045437647

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
118398628
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
00850045437381Virtue2004010012024-12-02
00850045437398Virtue2004020022024-12-02
00850045437404Virtue2004030032024-12-02
00850045437473Virtue2004040042024-12-02
00850045437480Virtue2004050052024-12-02
00850045437497Virtue2004060062024-12-02
20850045437385Virtue2004010012024-12-02
20850045437392Virtue2004020022024-12-02
20850045437408Virtue2004030032024-12-02
20850045437477Virtue2004040042024-12-02
20850045437484Virtue2004050052024-12-02
20850045437491Virtue2004060062024-12-02
00850045437961Nephron Nitrile2002060062024-05-30
20850045437965Nephron Nitrile2002060062024-05-30
00850045437916Nephron Nitrile2002010012024-04-26
00850045437923Nephron Nitrile2002020022024-04-26
00850045437930Nephron Nitrile2002030032024-04-26
00850045437947Nephron Nitrile2002040042024-04-26
00850045437954Nephron Nitrile2002050052024-04-26
20850045437910Nephron Nitrile2002010012024-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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