FDA.reportPublic FDA data

Patient Nitrile Examination Gloves blue2

Primary DI
16975878910533
Brand
Patient Nitrile Examination Gloves blue2
Company
shenzhenshishentongdianziyouxiangongsi
Model
Standard53
Device description
Disposable nitrile gloves are made from butadiene rubber latex by vulcanizing, dipping and drying.It is applicable to the general medical examination of the hospital.
Published
2024-01-04
Public version status
New
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
K121526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121526000POWER-FREE NITRILE PATIENT EXAMINATION GLOVESShandong Junchi Medical Products Co., Ltd.2012-08-03LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26975878910530PackageGS11000In Commercial Distribution
36975878910537PackageGS12000In Commercial Distribution
16975878910533PrimaryGS10
06975878910536Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697587891053026975878910530
3697587891053736975878910537
1697587891053316975878910533
06975878910536069758789105366975878910536

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
418640391
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16975878910052PEIPU Patient Nitrile Examination Gloves (blue)Standard052022-11-17
16975878910069PEIPU Patient Nitrile Examination Gloves (blue)Standard062022-11-17
16975878910076PEIPU Patient Nitrile Examination Gloves (blue)Standard072022-11-17
16975878910083PEIPU Patient Nitrile Examination Gloves (blue)Standard082022-11-17
16975878910540PEIPUStandard542024-05-01
16975878910557PEIPUStandard552024-05-01
16975878910564PEIPUStandard562024-05-01
16975878910571PEIPUStandard572024-05-01
16975878910588PEIPUStandard582024-05-01
16975878910595PEIPU Standard592024-05-01
16975878910601PEIPU Standard602024-05-01
16975878910618PEIPU Standard612024-05-01
16975878910625PEIPU Standard622024-05-01
16975878910632PEIPU Standard632024-05-01
16975878910649PEIPU Standard642024-05-01
16975878910656PEIPU Standard652024-05-01
16975878910663PEIPU Standard662024-05-01
16975878910670PEIPU Standard672024-05-01
16975878910687PEIPU Standard682024-05-01
16975878910694PEIPU Standard692024-05-01

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