FDA.reportPublic FDA data

Patient Nitrile Examination Gloves blue2

Primary DI
26975878910486
Brand
Patient Nitrile Examination Gloves blue2
Company
shenzhenshishentongdianziyouxiangongsi
Model
Standard48
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
Rx
false
OTC
true
Sterile
false
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
26975878910486PackageGS13000In Commercial Distribution
16975878910489PrimaryGS10
06975878910482Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697587891048626975878910486
1697587891048916975878910489
06975878910482069758789104826975878910482

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
418640391
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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