FDA.reportPublic FDA data

Akers

Primary DI
00759326041241
Brand
Akers
Company
Akers Industries, Inc.
Model
bn104
Device description
xlarge 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
00759326041241PrimaryGS10
00759326041340Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00759326041241007593260412417593260412410759326041241
00759326041340007593260413407593260413400759326041340

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
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
00759326041227Akersbn1022022-11-09
00759326041234Akersbn1032022-11-09
00759326076038Akersg603-pf2022-11-09
00759326084002Akersg8002022-11-09
00759326084019Akersg8012022-11-09
00759326084026Akersg8022022-11-09
00759326084033Akersg8032022-11-09
00759326084040Akersg8042022-11-09

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Primary DI, Brand, Company table
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10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641279Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641286Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641293Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641309Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641316Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641323Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641330Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641347Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
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00199536000025BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
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00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
00860010400937LuvatekR&C Imports LLCLZA2026-07-29
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22