FDA.reportPublic FDA data

CareMates

Primary DI
10715912056133
Brand
CareMates
Company
Shepard Medical Products, Inc.
Model
05613020
Device description
CareMates 50ct Nitrile Exam Gloves, large
Published
2023-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10715912056133PrimaryGS10
00715912056136Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071591205613310715912056133
00715912056136007159120561367159120561360715912056136

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.

Contacts#

Phone, Email table
PhoneEmail
630-539-7790info@shepard-medical.com

Regulatory Flags#

DUNS number
609079769
Device count
50

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10087701431224Good Neighbor101871332023-01-06
10087701431231Good Neighbor101871312023-01-06
10087701431248Good Neighbor101871342023-01-06
10087701434423Good Neighbor102643902023-01-06
10096295122296Leader45598602023-01-06
10715912014133CareMates014130202023-01-06
10715912016137CareMates016130202023-01-06
10715912016335WorkMates016330902023-01-06
10715912053118CareMates053110202023-01-06
10715912053125CareMates053120202023-01-06
10715912053132CareMates053130202023-01-06
10715912053415UltiMates053410802023-01-06
10715912053422UltiMates053420802023-01-06
10715912053439UltiMates053430802023-01-06
10715912053446UltiMates053440802023-01-06
10715912054115CareMates054110202023-01-06
10715912054122CareMates054120202023-01-06
10715912054139CareMates054130202023-01-06
10715912056119CareMates056110202023-01-06
10715912056126CareMates056120202023-01-06

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Primary DI, Brand, Company table
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