FDA.reportPublic FDA data

Medical Nitrile Examination Gloves (Power free, Blue)

Primary DI
16920756761974
Brand
Medical Nitrile Examination Gloves (Power free, Blue)
Company
Jiangxi Hongda Medical Equipment Group Ltd.
Model
S
Device description
textured surface, powder free
Published
2021-08-31
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
K210578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210578000Medical Nitrile Examination Gloves (Power free, Blue)Jiangxi Hongda Medical Equipment Group , Ltd.2021-07-10LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26920756761971PackageGS110In Commercial Distribution
36920756761978PackageGS120In Commercial Distribution
16920756761974PrimaryGS10
06920756761977Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2692075676197126920756761971
3692075676197836920756761978
1692075676197416920756761974
06920756761977069207567619776920756761977

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
526963345
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
16920756761905Medical Nitrile Examination Gloves (Power free, Blue)XL2021-08-31
16920756761912Medical Nitrile Examination Gloves (Power free, Blue)XL2021-08-31
16920756761929Medical Nitrile Examination Gloves (Power free, Blue)L2021-08-31
16920756761936Medical Nitrile Examination Gloves (Power free, Blue)L2021-08-31
16920756761943Medical Nitrile Examination Gloves (Power free, Blue)M2021-08-31
16920756761950Medical Nitrile Examination Gloves (Power free, Blue)M2021-08-31
16920756761967Medical Nitrile Examination Gloves (Power free, Blue)S2021-08-31
16920756761981Medical Nitrile Examination Gloves (Power free, Blue)XS2021-08-31
16920756761998Medical Nitrile Examination Gloves (Power free, Blue)XS2021-08-31
26920756761902Medical Nitrile Examination Gloves (Power free, Blue)XL2021-08-31
26920756761919Medical Nitrile Examination Gloves (Power free, Blue)XL2021-08-31
26920756761926Medical Nitrile Examination Gloves (Power free, Blue)L2021-08-31
26920756761933Medical Nitrile Examination Gloves (Power free, Blue)L2021-08-31
26920756761940Medical Nitrile Examination Gloves (Power free, Blue)M2021-08-31
26920756761957Medical Nitrile Examination Gloves (Power free, Blue)M2021-08-31
26920756761964Medical Nitrile Examination Gloves (Power free, Blue)S2021-08-31
26920756761971Medical Nitrile Examination Gloves (Power free, Blue)S2021-08-31
26920756761988Medical Nitrile Examination Gloves (Power free, Blue)XS2021-08-31
26920756761995Medical Nitrile Examination Gloves (Power free, Blue)XS2021-08-31
06920756728383Sterile Single-use Syringe with Needle60mL LL2021-03-29

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