FDA.reportPublic FDA data

Beesure

Primary DI
00817508021969
Brand
Beesure
Company
ASCEND EAGLE INCORPORATED
Model
BE1185
Device description
Beesure NeoGrene Chloroprene Exam Powder Free Gloves 200 /BX , Green XS
Published
2020-06-08
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

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
20817508021963PackageGS110In Commercial Distribution
00817508021969PrimaryGS10
10817508021966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081750802196320817508021963
00817508021969008175080219698175080219690817508021969
1081750802196610817508021966

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
7075536190jordan.lim@pro2s.com

Regulatory Flags#

DUNS number
167102750
Device count
200
DM exempt
false
Premarket exempt
true
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
10817508022260CranberryCR39052025-09-02
20817508022298CranberryCR39062025-09-02
20817508022328CranberryCR39072025-09-02
20817508023134CranberryCR39082025-09-02
20817508023868CranberryCR39092025-09-02
20817508020089CranberryCR35752025-05-08
20817508020218CranberryCR35762025-05-08
20817508020324CranberryCR35772025-05-08
20817508020379CranberryCR35782025-05-08
20817508021710CranberryCR35792025-05-08
20817508023004ASAP205712022-07-07
20817508023028ASAP205722022-07-07
20817508023035ASAP205732022-07-07
20817508023059ASAP205742022-07-07
20817508023066ASAP205752022-07-07
20817508023226ASAP207112022-07-07
20817508023233ASAP207122022-07-07
20817508023240ASAP207132022-07-07
20817508023257ASAP207142022-07-07
20817508023264ASAP207152022-07-07

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