FDA.report

Cranberry

Primary DI
00817508021150
Brand
Cranberry
Company
ASCEND EAGLE INCORPORATED
Model
CR7818
Device description
Silkcare Latex Powder Free Exam Gloves, L - Inner Pack
Published
2021-12-15
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

Related Records

Contact Domains

Product Codes

CodeName
LYYLatex Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20817508021154PackageGS110In Commercial Distribution
10817508021157PrimaryGS10
00817508021150Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081750802115420817508021154
1081750802115710817508021157
00817508021150008175080211508175080211500817508021150

GMDN Terms

TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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
100
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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

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