FDA.reportPublic FDA data

Burkhart Dental Supply

Primary DI
00815878028441
Brand
Burkhart Dental Supply
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72720986
Device description
Burkhart Green SM Chloroprene PF Txt Gloves (200)
Published
2021-05-14
Public version status
Update
Distribution status
Not 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
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
00815878028441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815878028441008158780284418158780284410815878028441

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA non-sterile 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 talcum powder and it does not have antimicrobial features. 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

Contacts#

Phone, Email table
PhoneEmail
800-562-8176customerservice@burkhartdental.com

Regulatory Flags#

DUNS number
027532357
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810052610306Burkhart Dental Supply727218402024-01-15
00810052610313Burkhart Dental Supply727218412024-01-15
00810052610320Burkhart Dental Supply727218422024-01-15
00810052610337Burkhart Dental Supply727218432024-01-15
00810052610696Burkhart Dental Supply727218442024-01-15
00815878020100Burkhart Select Multivariable Sterilization Pouch 5 1/4X10 (200)727206602016-09-16
00815878020117Burkhart Select Multivariable Sterilization Pouch 2 3/4 X 9 (200)727206612016-09-16
00815878020124Burkhart Select Multivariable Sterilezation Pouch 3 1/2 x 5 1/4 (200)727206632016-09-16
00815878020131Burkhart Select Multivariable Sterilization Pouch 3-1/2 x 9 (200)727206622016-09-16
00815878021053"Burkhart Sterile Pouches 7-1/2"" x 13"" (200)"727208432018-04-13
00815878027628Burkhart Dental Supply727220272024-05-07
00815878027642Burkhart Dental Supply727220292024-05-07
00854212006165Burkhart Etching Gel 2-5ml Syringes 37.5% w/20-22ga Tips727204242016-09-16
00815878028397Burkhart Dental Supply727209812024-12-06
00815878028403Burkhart Dental Supply727209822024-12-06
00815878028410Burkhart Dental Supply727209832024-12-06
00815878028427Burkhart Dental Supply727209842024-12-06
00854212006004"Burkhart 3-0 Chromic Gut Suture 18"", C-6 Needle"727207652016-03-03
00854212006011"Burkhart 3-0 Chromic Suture 27"", C-6 Needle"727207612016-03-03
00854212006028"Burkhart 3-0 Plain Gut Suture 18"", C-6 Needle"727207512016-03-03

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