FDA.reportPublic FDA data

UltiMates

Primary DI
10715912053439
Brand
UltiMates
Company
Shepard Medical Products, Inc.
Model
05343080
Device description
UltiMates 50ct High Risk Latex 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
LYYLatex Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10715912053439PrimaryGS10
00715912053432Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071591205343910715912053439
00715912053432007159120534327159120534320715912053432

GMDN Terms#

Term, Definition table
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.

Contacts#

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

Regulatory Flags#

DUNS number
609079769
Device count
50
Contains natural rubber latex
true

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
10715912053446UltiMates053440802023-01-06
10715912054115CareMates054110202023-01-06
10715912054122CareMates054120202023-01-06
10715912054139CareMates054130202023-01-06
10715912056119CareMates056110202023-01-06
10715912056126CareMates056120202023-01-06
10715912056133CareMates056130202023-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557407Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557438Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557469Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557490Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12