FDA.reportPublic FDA data

Beesure

Primary DI
00817508020504
Brand
Beesure
Company
ASCEND EAGLE INCORPORATED
Model
BE2946
Device description
Naturals Forest Nitrile Power Free Exam Gloves - S
Published
2020-06-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817508020508PackageGS110In Commercial Distribution
10817508020501PrimaryGS10
00817508020504Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081750802050820817508020508
1081750802050110817508020501
00817508020504008175080205048175080205040817508020504

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile 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 and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). 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
1
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
10817508022291CranberryCR39062025-09-02
10817508022321CranberryCR39072025-09-02
10817508023137CranberryCR39082025-09-02
10817508023861CranberryCR39092025-09-02
10817508022260CranberryCR39052025-09-02
20817508022298CranberryCR39062025-09-02
20817508022328CranberryCR39072025-09-02
20817508023134CranberryCR39082025-09-02
20817508023868CranberryCR39092025-09-02
10817508020082CranberryCR35752025-05-08
10817508020211CranberryCR35762025-05-08
10817508020327CranberryCR35772025-05-08
10817508020372CranberryCR35782025-05-08
10817508021713CranberryCR35792025-05-08
20817508020089CranberryCR35752025-05-08
20817508020218CranberryCR35762025-05-08
20817508020324CranberryCR35772025-05-08
20817508020379CranberryCR35782025-05-08
20817508021710CranberryCR35792025-05-08
10817508021249BeesureBE13222022-05-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
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00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531065Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531133Maxter BlueMaxter Healthcare IncorporatedLZA2026-10-15
00850069531140Maxter BlueMaxter Healthcare IncorporatedLZA2026-10-15
00850069531157Maxter BlueMaxter Healthcare IncorporatedLZA2026-10-15
00850069531164Maxter BlueMaxter Healthcare IncorporatedLZA2026-10-15
00850069531171Maxter BlueMaxter Healthcare IncorporatedLZA2026-10-15
00850069531188Maxter BlueMaxter Healthcare IncorporatedLZA2026-10-15
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10810141933931VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCLZA2026-10-07
00850054870544BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01