FDA.reportPublic FDA data

ASTRO GRIP

Primary DI
00781311005181
Brand
ASTRO GRIP
Company
Bunzl USA Holdings LLC
Model
66474-06
Device description
disposable nitrile gloves, powder-free, orange, 6pk
Published
2025-04-04
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00781311005181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00781311005181007813110051817813110051810781311005181

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

Regulatory Flags#

DUNS number
799540588
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00727351800898SH GLOVEM2650025M26500252024-04-02
00727351800904SH GLOVEM2650026M26500262024-04-12
00727351800911SH GLOVEM2650027M26500272024-04-12
00727351800928SH GLOVEM2650028M26500282024-04-12
00727351800935SH GLOVEM2650029M26500292024-04-26
00727351800959SH GLOVEM2650031M26500312024-04-26
00727351800966SH GLOVEM2650032M26500322024-04-26
00727351800942SH GLOVEM2650030M26500302024-04-26
00781311660649DERMA MAX6606-402024-03-28
00781311660748DERMA MAX6607-402024-03-28
00781311660847DERMA MAX6608-402024-03-28
00781311660946DERMA MAX6609-402024-03-28
00781311661042DERMA MAX6610-402024-03-28
10781311660646Derma Max6606-406606-402022-10-21
10781311660745Derma Max6607-406607-402022-10-21
10781311660844Derma Max6608-406608-402022-10-21
10781311660943Derma Max6609-406609-402022-10-21
10781311661049Derma Max6610-406610-402022-10-21
00781311701212Raptor Grip6160808C2025-06-27
00781311701243Raptor Grip6161108C2025-06-27

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