FDA.reportPublic FDA data

Akers

Primary DI
00759326741042
Brand
Akers
Company
Akers Industries, Inc.
Model
n104-lc
Device description
xlarge powder free nitrile examination gloves
Published
2022-10-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00759326741042PrimaryGS10
00759326741141Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00759326741042007593267410427593267410420759326741042
00759326741141007593267411417593267411410759326741141

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.

Regulatory Flags#

DUNS number
790695126
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00759326741035Akersn103-lc2022-10-20
00759326041005Akersn1002022-10-20
00759326049117Akersn4000s2022-10-27
00759326204202Akersv4202022-10-27
00759326204219Akersv4212022-10-27
00759326204226Akersv4222022-10-27
00759326204233Akersv4232022-10-27
00759326204301Akersv4202022-10-27
00759326204318Akersv4212022-10-27
00759326204325Akersv4222022-10-27
00759326204332Akersv4232022-10-27
00759326041227Akersbn1022022-11-09
00759326041234Akersbn1032022-11-09
00759326041241Akersbn1042022-11-09
00759326076038Akersg603-pf2022-11-09
00759326084002Akersg8002022-11-09
00759326084019Akersg8012022-11-09
00759326084026Akersg8022022-11-09
00759326084033Akersg8032022-11-09
00759326084040Akersg8042022-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952153NeulynxMedgluv Inc.LZA2026-06-26
10304040194048EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194055EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194062EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194079EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194086EssentialsHENRY SCHEIN, INC.LZA2026-06-25
00050428426777CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLZA2026-06-24
00884389961196CURADMEDLINE INDUSTRIES, INC.LZA2026-06-23
00884389961202CURADMEDLINE INDUSTRIES, INC.LZA2026-06-23
00196633795946Kirkland SignatureCostco Wholesale CorporationLZA2026-06-17
00840546402292sunnycareAgio Group Inc.LZA2026-06-10
00840546402315sunnycareAgio Group Inc.LZA2026-06-10
00840546402339sunnycareAgio Group Inc.LZA2026-06-10
00840546402353sunnycareAgio Group Inc.LZA2026-06-10
00840546402377sunnycareAgio Group Inc.LZA2026-06-10
00840546402391sunnycareAgio Group Inc.LZA2026-06-10
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04