FDA.reportPublic FDA data

ESTEEM

Primary DI
50885380176966
Brand
ESTEEM
Company
Cardinal Health 200, LLC
Model
88SNS05XL
Catalog number
88SNS05XL
Device description
Nitrile Exam Gloves
Published
2021-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZCPatient examination glove, specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380176965PackageGS1100In Commercial Distribution
50885380176966PackageGS14In Commercial Distribution
10885380176968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538017696520885380176965
5088538017696650885380176966
1088538017696810885380176968

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

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850006162611Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162628Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162796Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162758Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162765Aloe-ShieldClinical Supply CompanyLZC2026-03-24
30680651489532HalyardO&M HALYARD, INC.LZC2026-03-12
00810194400278AiraAIRA, LLCLZC2026-02-10
00810007662534HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662541HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662558HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662565HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662572HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662602HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00847713001340microdot® FlexCambridge Sensors USA LLCLZC2025-12-12
00847713001258microdot® FlexCambridge Sensors USA LLCLZC2025-12-12
10842942014151PRIMEDpriMED Medical Products IncLZC2025-11-18
40080196334255MEDLINEMEDLINE INDUSTRIES, INC.LZC2025-07-17
00810194400261AiraAIRA, LLCLZC2025-07-16
00850061859174GCB Medical SupplyGCB MEDICAL LLCLZC2025-07-09
00850061859082GCB Medical SupplyGCB MEDICAL LLCLZC2025-07-09
00850061859198GCB Medical SupplyGCB MEDICAL LLCLZC2025-07-09
20076490730592KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490748658KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490754888KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490755069KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490763101KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490763743KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490768878KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490723617KIMTECHAnsell Healthcare ProductLZC2025-07-02
20076490730158KIMTECHAnsell Healthcare ProductLZC2025-07-02