FDA.reportPublic FDA data

Health-Tec/DHP Chloroprene Gloves

Primary DI
D773430C200M1
Brand
Health-Tec/DHP Chloroprene Gloves
Company
Dental Health Products Inc
Model
430-C200M
Catalog number
430-C200M
Device description
Health-Tec/DHP Chloroprene Gloves - Size Medium 200/box
Published
2022-09-21
Public version status
New
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
D773430C200M1PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
623191194
Device count
1
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
D7735901000721DHP/Health-Tec Sterilization Tape 590-100072590-1000722023-03-24
D7735901000821DHP/Health-Tec Sterilization Tape590-100082590-1000822023-03-24
D7736001000320DHP/Health-Tec Sterilization Pouches600-100032600-1000322023-03-23
D7736001000420DHP/Health-Tec Sterilization Pouches600-100042600-1000422023-03-23
D7736001000520DHP/Health-Tec Sterilization Pouches600-100052600-1000522023-03-23
D7736001000620DHP/Health-Tec Sterilization Pouches600-100062600-1000622023-03-23
D7736001000720DHP/Health-Tec Sterilization Pouches600-100072600-1000722023-03-23
D7736001000820DHP/Health-Tec Sterilization Pouches600-100082600-1000822023-03-23
D7736001000920DHP/Health-Tec Sterilization Pouches600-100092600-1000922023-03-23
D7736001001020DHP/Health-Tec Sterilization Pouches600-100102600-1001022023-03-23
D7736001001120DHP/Health-Tec Sterilization Pouches600-100112600-1001122023-03-23
D773970100010Health-Tec/DHP Disposable Prophy Angles970-10001970-100012022-11-28
D773970100020Health-Tec/DHP Disposable Prophy Angles970-10002970-100022022-11-28
D7739705220140Health-Tec/DHP Disposable Prophy Angles970-522014970-5220142022-11-28
D773970522140Health-Tec/DHP Disposable Prophy Angles970-522114970-5221142022-11-28
D7739705224140Health-Tec/DHP Disposable Prophy Angles970-522414970-5224142022-11-28
D7739705225140Health-Tec/DHP Disposable Prophy Angles970-522514970-5225142022-11-28
D773930100060Health-Tec/DHP PSP Barrier Envelopes930-10006930-100062022-11-14
D773930HTBWT0Health-Tec/DHP Bite Wing Tabs930-HTBWT930-HTBWT2022-11-14
D773800100020Health-Tec/DHP Matrix Bands800-10002800-100022022-11-10

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
20850455007437Advance 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