FDA.reportPublic FDA data

STEELFLEX

Primary DI
00850040723298
Brand
STEELFLEX
Company
American Nitrile Operations, LLC
Model
ANST354
Catalog number
ANST354
Device description
STEELFLEX SIZE L, Blue Nitrile Powder-Free, Chemo and Fentanyl Resistant Patient Examination Glove
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
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
K220825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220825000Sapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC2022-07-08LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040723298PackageGS110In Commercial Distribution
00850040723144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040723298008500407232988500407232980850040723298
00850040723144008500407231448500407231440850040723144

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

Contacts#

Phone, Email table
PhoneEmail
614-600-2655xx@xx.xx

Regulatory Flags#

DUNS number
118378851
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040723052STEELFLEXANST356ANST3562024-02-14
00850040723090SLATEANSL455ANSL4552024-02-14
00850040723151STEELFLEXANST355ANST3552024-02-14
00850040723311SLATEANSL456ANSL4562024-02-14
00850040723250STEELFLEXANST356ANST3562024-02-14
00850040723243SLATEANSL455ANSL4552024-02-14
00850040723106SLATEANSL451ANSL4512024-02-14
00850040723113STEELFLEXANST351ANST3512024-02-14
00850040723304STEELFLEXANST355ANST3552024-02-14
00850040723328SLATEANSL456ANSL4562024-02-14
00850040723076SLATEANSL453ANSL4532023-02-17
00850040723083SLATEANSL454ANSL4542023-02-17
00850040723120STEELFLEXANST352ANST3522023-02-17
00850040723137STEELFLEXANST353ANST3532023-02-17
00850040723144STEELFLEXANST354ANST3542023-02-17
00850040723069SLATEANSL452ANSL4522023-02-17
00850040723229SLATEANSL453ANSL4532023-02-17
00850040723236SLATEANSL454ANSL4542023-02-17
00850040723274STEELFLEXANST352ANST3522023-02-17
00850040723281STEELFLEXANST353ANST3532023-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
00810145952108NeuleafMedgluv Inc.LZA2026-06-29
00850005229568NeuflexMedgluv Inc.LZA2026-06-29
00850005229575NeuflexMedgluv Inc.LZA2026-06-29
00850005229582NeuflexMedgluv Inc.LZA2026-06-29
00850005229599NeuflexMedgluv Inc.LZA2026-06-29
00850005229605NeuflexMedgluv Inc.LZA2026-06-29
00850005229612NeuflexMedgluv Inc.LZA2026-06-29
00810145951972NeuPro 16Medgluv Inc.LZA2026-06-26
00810145951989NeuPro 16Medgluv Inc.LZA2026-06-26
00810145951996NeuPro 16Medgluv Inc.LZA2026-06-26
00810145952009NeuPro 16Medgluv Inc.LZA2026-06-26