FDA.reportPublic FDA data

Advance Dental Products

Primary DI
20850455007437
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
43350
Device description
Advance Chloroprene Gloves X-Large
Published
2022-12-08
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
20850455007437PackageGS110In Commercial Distribution
10850455007430PrimaryGS10
00850455007433Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085045500743720850455007437
1085045500743010850455007430
00850455007433008504550074338504550074330850455007433

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
033505389
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00371347021974Advance Dental ProductsPR018HC2026-01-15
00371347022131Advance Dental ProductsPM018HC2026-01-15
00371347021028Advance Dental ProductsAPT1012026-01-15
00371347021035Advance Dental ProductsAPT1022026-01-15
00371347021042Advance Dental ProductsAPT1032026-01-15
00371347021059Advance Dental ProductsAPT1042026-01-15
00371347021066Advance Dental ProductsAPT1052026-01-15
00371347021073Advance Dental ProductsAPT1082026-01-15
00371347021080Advance Dental ProductsAPT1092026-01-15
00371347021097Advance Dental ProductsAPT1102026-01-15
00371347021103Advance Dental ProductsAPT1112026-01-15
00371347021110Advance Dental ProductsAPT1122026-01-15
00371347021127Advance Dental ProductsAPT1132026-01-15
00371347021134Advance Dental ProductsAPT1162026-01-15
00371347021141Advance Dental ProductsAPT1172026-01-15
00371347021158Advance Dental ProductsAPT1182026-01-15
00371347021165Advance Dental ProductsAPT1202026-01-15
00371347021172Advance Dental ProductsAPT1212026-01-15
00371347021189Advance Dental ProductsAPT1242026-01-15
00371347021196Advance Dental ProductsAPT1252026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D6620705854630Patterson®PATTERSON DENTAL SUPPLY, INC.OPC2024-11-11
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
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
TQ26PC002Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC102Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC302Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC402Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC502Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PCP002Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PCP102Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
20850002097102BlackworkBlackwork Worldwide LLCOPC2023-01-30
20850002097119BlackworkBlackwork Worldwide LLCOPC2023-01-30
20850002097126BlackworkBlackwork Worldwide LLCOPC2023-01-30
20850002097133BlackworkBlackwork Worldwide LLCOPC2023-01-30
20850002097140BlackworkBlackwork Worldwide LLCOPC2023-01-30
20850455007390Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2022-12-08
20850455007406Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2022-12-08
20850455007413Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2022-12-08
20850455007420Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2022-12-08
30813172023149Pulse® CR AquaINNOVATIVE HEALTHCARE CORPORATIONOPC2022-12-08
30813172023156Pulse® CR AquaINNOVATIVE HEALTHCARE CORPORATIONOPC2022-12-08
30813172023163Pulse® CR AquaINNOVATIVE HEALTHCARE CORPORATIONOPC2022-12-08
30813172023170Pulse® CR AquaINNOVATIVE HEALTHCARE CORPORATIONOPC2022-12-08
40813172023184Pulse® CR AquaINNOVATIVE HEALTHCARE CORPORATIONOPC2022-12-08
10813172024883Pulse® CR AquaINNOVATIVE HEALTHCARE CORPORATIONOPC2022-12-08