FDA.reportPublic FDA data

Blackwork

Primary DI
20850002097102
Brand
Blackwork
Company
Blackwork Worldwide LLC
Model
1010
Device description
Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Black, XS
Published
2023-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850002097102PackageGS110In Commercial Distribution
10850002097105PrimaryGS10
00850002097108Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085000209710220850002097102
1085000209710510850002097105
00850002097108008500020971088500020971080850002097108

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045085221
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
10850002097105Blackwork10102023-01-30
10850002097112Blackwork10202023-01-30
10850002097129Blackwork10302023-01-30
10850002097136Blackwork10402023-01-30
10850002097143Blackwork10502023-01-30
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
00889813067994Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068007Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068021Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068038Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068045Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
D6620705854632Patterson®PATTERSON DENTAL SUPPLY, INC.OPC2024-11-11
D6620705854630Patterson®PATTERSON DENTAL SUPPLY, INC.OPC2024-11-11
10850002458173Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
10850002458180Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
10850002458197Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00371347010909Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00371347011258Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
10371347011255Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00850002458176Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00850002458190Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
30813172023095Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
30813172023118Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
30813172023132Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
40813172023122Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
40813172023092Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
40813172023115Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
00813172023131Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
50813172023129Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
TQ26PC001Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC101Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC301Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC401Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC501Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PCP001Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PCP101Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06