FDA.reportPublic FDA data

Beesure

Primary DI
00817508020474
Brand
Beesure
Company
ASCEND EAGLE INCORPORATED
Model
BE2928
Device description
Naturals Glacier Nitrile Power Free Exam Gloves - L
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
true
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
20817508020478PackageGS110In Commercial Distribution
10817508020471PrimaryGS10
00817508020474Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081750802047820817508020478
1081750802047110817508020471
00817508020474008175080204748175080204740817508020474

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
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00850016052056NiTouchKasa Trading, LLCLZA2026-08-03
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