FDA.reportPublic FDA data

ESTEEM

Primary DI
20885380137164
Brand
ESTEEM
Company
Cardinal Health 200, LLC
Model
8815NB
Catalog number
8815NB
Device description
ESTEEM STRETCH
Published
2019-01-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110960000ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREEKoon Seng Sdn Bhd2011-07-14LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380137165PackageGS110Not in Commercial Distribution
20885380137164PrimaryGS10
10885380137167Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538013716550885380137165
2088538013716420885380137164
1088538013716710885380137167

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.

Regulatory Flags#

DUNS number
961027315
Device count
150
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956141018CARDINAL HEALTHSNEHFNSASASNEHFNSASA2026-10-06
10198956171954CARDINAL HEALTHSCVCGCVMHCSCVCGCVMHC2026-10-06
10198956286672CARDINAL HEALTHPOV20110MPOV20110M2026-10-06
10198956301511CARDINAL HEALTHSOPPDKRROCSOPPDKRROC2026-10-06
10198956306059CARDINAL HEALTHSOP51SHSRGSOP51SHSRG2026-10-06
10198956314351CARDINAL HEALTHSNE8BSPBPGSNE8BSPBPG2026-10-06
10198956339156CARDINAL HEALTHOR2224609BOR2224609B2026-10-06
10198956340268CARDINAL HEALTHSAN22IPMRDSAN22IPMRD2026-10-06
10198956348776CARDINAL HEALTHPL23CEMEFPL23CEMEF2026-10-06
10198956354494CARDINAL HEALTHSOPHFAPMRCSOPHFAPMRC2026-10-06
10198956362666CARDINAL HEALTHSOT54CPDRCSOT54CPDRC2026-10-06
10198956371019CARDINAL HEALTHSER5BCLHCCSER5BCLHCC2026-10-06
10198956379824CARDINAL HEALTHSOP21SAFECSOP21SAFEC2026-10-06
10198956391215CARDINAL HEALTHSANDHAGFHCSANDHAGFHC2026-10-06
10198956397859CARDINAL HEALTH34-9706C34-9706C2026-10-06
10198956399129CARDINAL HEALTH26-7824E26-7824E2026-10-06
10198956401846CARDINAL HEALTH34-3264R34-3264R2026-10-06
10198956402416CARDINAL HEALTHSOP13OHEXESOP13OHEXE2026-10-06
10198956420526CARDINAL HEALTHSAN4ATPJHCSAN4ATPJHC2026-10-06
10198956439535CARDINAL HEALTHSEN69ESKODSEN69ESKOD2026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054870544BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
00662956201063Body Guard[Fastenal CompanyLZA2026-09-30
00662956201285Body Guard[Fastenal CompanyLZA2026-09-30
00662956202558Body GuardFastenal CompanyLZA2026-09-30
00662956203258Body GuardFastenal CompanyLZA2026-09-30
00662956203661BodyguardFastenal CompanyLZA2026-09-30
00662956203760BodyguardFastenal CompanyLZA2026-09-30
00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
00199536900219BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03