BYD CARE

Primary DI
06974528640069
Brand
BYD CARE
Company
BYD Auto Industry Company Limited
Model
NE01
Device description
Size L
Published
2021-12-29
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
K212840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212840000Nitrile Gloves (Model: NE01)Byd Auto Industry Company Limited2021-12-11LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974528640066PackageGS110In Commercial Distribution
06974528640069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697452864006616974528640066
06974528640069069745286400696974528640069

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
545351723
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974528640045BYD CARENE012021-12-29
06974528640052BYD CARENE012021-12-29
06974528640076BYD CARENE012021-12-29
16974528640042BYD CARENE012021-12-29
16974528640059BYD CARENE012021-12-29
16974528640066BYD CARENE012021-12-29
16974528640073BYD CARENE012021-12-29

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Primary DI, Brand, Company table
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20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
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