FDA.reportPublic FDA data

Meijer

Primary DI
00708820383722
Brand
Meijer
Company
MEIJER, INC.
Model
MJ4045V3
Catalog number
MJ4045V3
Device description
GLOVE,EXAM,NITRILE,PF,LF,50CT,OSFM
Published
2024-10-04
Public version status
Update
Distribution status
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
K170136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170136000Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Feiyang Professional Gloves Co., Ltd.2017-08-25LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20708820383726PackageGS1200In Commercial Distribution
30708820383723PackageGS11200In Commercial Distribution
00708820383722PrimaryGS10
80080196025748Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2070882038372620708820383726
3070882038372330708820383723
00708820383722007088203837227088203837220708820383722
8008019602574880080196025748

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, avoid excessive heat. Keep dry. Should be shielded from direct sunlight, fluorescent lighting, x-rays, moisture and ozone.

Regulatory Flags#

DUNS number
006959555
Device count
50
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00713733712835MeijerMJ4035V130522902026-06-05
00719283515964meijer71928351596443238042019-07-30
00713733293129MEIJERMJFAK150V2MJFAK150V22026-04-20
00760236195603MeijerMJFAKMINIMJFAKMINI2026-04-20
00760236195771Meijer20002290N/A2026-04-01
00760236195818Meijer20002291N/A2026-04-01
00760236264811Meijer Advanced One Step Pregnancy Test2020-10-02
00760236264828Meijer Advanced Early Result Pregnancy Test2020-10-02
00760236471646Meijer Saline Wound Wash 95-50740-200-002026-03-06
00719283501233Meijer74-9713487072020-12-07
00719283501288Meijer74-9732020-12-07
00719283338334Meijer Hot & Cold Compression Migraine Mask7192833383342024-04-03
00708820957367Meijer, instant cold pack, value pack 36501102021-02-04
00708820957473Meijer, instant cold pack 36501092020-07-21
00708820519541Meijer Hot/Cold Back Pad34572442017-08-01
00708820519558Meijer Hot & Cold Wrap Ultra-Forming 34572462017-08-01
00708820523418Meijer Hot & Cold Therapy Wrap with Clay Based Technology34583982017-08-01
00708820523425Meijer Hot & Cold Beads Compress with Strap34583972017-08-01
00708820523432Meijer Moist Heat Neck Wrap34583962017-08-01
00760236195696Meijer57005082025-12-24

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Primary DI, Brand, Company table
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20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
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20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
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10840330706787ProCureTwin Med, LLCLZA2026-06-01