FDA.reportPublic FDA data

Nception

Primary DI
00810131090661
Brand
Nception
Company
Strong Medical Partners LLC
Model
71043
Catalog number
GN403
Device description
Nception GN403 Nitrile Exam Gloves, Blue, Powder Free, Size Medium (M), Non-Sterile, 1,000 ea per case
Published
2023-11-03
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810131090668PackageGS11000In Commercial Distribution
00810131090661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013109066810810131090668
00810131090661008101310906618101310906610810131090661

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store under cool, dry conditions. Avoid direct sunlight.

Contacts#

Phone, Email table
PhoneEmail
704-684-1891info@nceptionbrands.com

Regulatory Flags#

DUNS number
062388929
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040791174Strong Manufacturers710171012022-08-19
00810757021056Sam Tell Companies75043NG4PFMD-BK2024-01-12
00810757021063Sam Tell Companies75042NG4PFSM-BK2024-01-12
00810757021070Sam Tell Companies75045NG4PFXL-BK2024-01-12
00810757021049Sam Tell Companies75044NG4PFLG-BK2024-01-12
00810757020899Sam Tell Companies75043NG4PFMD-BK2024-01-12
00810757020905Sam Tell Companies75042NG4PFSM-BK2024-01-12
00810757020912Sam Tell Companies75045NG4PFXL-BK2024-01-12
00810131090609Nception71014GN3042023-11-03
00810131090616Nception71012GN3022023-11-03
00810131090623Nception71013GN3032023-11-03
00810131090630Nception71015GN3052023-11-03
00810131090647Nception71044GN4042023-11-03
00810131090654Nception71042GN4022023-11-03
00810131090678Nception71045GN4052023-11-03
00810131090685Nception75042GN402B2023-11-03
00810131090692Nception75043GN403B2023-11-03
00810131090708Nception75044GN404B2023-11-03
00810131090715Nception75045GN405B2023-11-03
10810131090606Nception71014GN3042023-11-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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.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