FDA.reportPublic FDA data

N-Dex

Primary DI
00038054686499
Brand
N-Dex
Company
SHOWA BEST GLOVE, INC.
Model
L
Catalog number
M7005PFL
Device description
"Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2"", 4-mil, rolled cuff, blue/Large"
Published
2023-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211003000SHOWA(R) Blue Nitrile Powder Free Medical Examination GloveShowa Best Glove, Inc.2022-01-19LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20038054686493PackageGS120In Commercial Distribution
00038054686499PrimaryGS10
10038054686496Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2003805468649320038054686493
00038054686499000380546864990380546864990038054686499
1003805468649610038054686496

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.

Contacts#

Phone, Email table
PhoneEmail
800-241-0323USA@Showagroup.com

Regulatory Flags#

DUNS number
807930412
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
00038054654306DermaThinXLM7002PFXL2023-03-31
00038054654313DermaThinXXLM7002PFXXL2023-03-31
00038054654375DermaThinSM7002PFS2023-03-31
00038054654382DermaThinMM7002PFM2023-03-31
00038054654399DermaThinLM7002PFL2023-03-31
10038054654303DermaThinXLM7002PFXL2023-03-31
10038054654310DermaThinXXLM7002PFXXL2023-03-31
00038054654368DermaThinXSM7002PFXS2023-03-31
10038054654372DermaThinSM7002PFS2023-03-31
10038054654389DermaThinMM7002PFM2023-03-31
10038054654396DermaThinLM7002PFL2023-03-31
00038054256104SHOWAXL5005PFXL2023-03-24
00038054256111SHOWAXXL5005PFXXL2023-03-24
00038054256166SHOWAXS5005PFXS2023-03-24
00038054256173SHOWAS5005PFS2023-03-24
00038054256180SHOWAM5005PFM2023-03-24
00038054256197SHOWAL5005PFL2023-03-24
10038054256101SHOWAXL5005PFXL2023-03-24
10038054256118SHOWAXXL5005PFXXL2023-03-24
10038054256163SHOWAXS5005PFXS2023-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZC2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZC2026-07-14
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
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LZC2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LZC2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LZC2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LZC2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06