FDA.reportPublic FDA data

Akers

Primary DI
00759326041227
Brand
Akers
Company
Akers Industries, Inc.
Model
bn102
Device description
Medium powder free black nitrile examination gloves
Published
2022-11-09
Public version status
New
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103670000NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)Innovative Gloves Co;, Ltd.2011-03-31LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00759326041227PrimaryGS10
00759326041326Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00759326041227007593260412277593260412270759326041227
00759326041326007593260413267593260413260759326041326

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, powderedA 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 covered with powder to facilitate donning/removal; 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/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
00759326741042Akersn104-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
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
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100PNK1MYNTMynt ProfessionalLZA2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15