FDA.report

Beesure

Primary DI
00817508022003
Brand
Beesure
Company
ASCEND EAGLE INCORPORATED
Model
BE1189
Device description
Beesure NeoGrene Chloroprene Exam Powder Free Gloves 200 /BX , Green XL
Published
2020-06-10
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

Related Records

Contact Domains

Product Codes

CodeName
OPCPowder-Free Polychloroprene Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
OPCPowder-Free Polychloroprene Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20817508022007PackageGS110In Commercial Distribution
00817508022003PrimaryGS10
10817508022000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081750802200720817508022007
00817508022003008175080220038175080220030817508022003
1081750802200010817508022000

GMDN Terms

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

Contacts

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

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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

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