FDA.reportPublic FDA data

Blackwork

Primary DI
10850002097136
Brand
Blackwork
Company
Blackwork Worldwide LLC
Model
1040
Device description
Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Black, L
Published
2023-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZCMedical Glove, Specialty
OPCPowder-Free Polychloroprene Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1
OPCPowder-Free Polychloroprene Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850002097133PackageGS110In Commercial Distribution
10850002097136PrimaryGS10
00850002097139Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085000209713320850002097133
1085000209713610850002097136
00850002097139008500020971398500020971390850002097139

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA device made of polychloroprene (neoprene) 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Regulatory Flags#

DUNS number
045085221
Device count
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850002097105Blackwork10102023-01-30
10850002097112Blackwork10202023-01-30
10850002097129Blackwork10302023-01-30
10850002097143Blackwork10502023-01-30
20850002097102Blackwork10102023-01-30
20850002097119Blackwork10202023-01-30
20850002097126Blackwork10302023-01-30
20850002097133Blackwork10402023-01-30
20850002097140Blackwork10502023-01-30
10850002097006Blackwork20102023-01-30
10850002097013Blackwork20202023-01-30
10850002097020Blackwork20302023-01-30
10850002097037Blackwork20402023-01-30
10850002097044Blackwork20502023-01-30
10850002097051Blackwork30102023-01-30
10850002097068Blackwork30202023-01-30
10850002097075Blackwork30302023-01-30
10850002097082Blackwork30402023-01-30
10850002097099Blackwork30502023-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850069531201Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531065Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531133Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531140Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531157Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531164Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531171Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531188Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10810141933931VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZC2026-10-07