FDA.reportPublic FDA data

Cureguard

Primary DI
06938275200778
Brand
Cureguard
Company
Jiangsu Cureguard Glove Co., Ltd.
Model
L
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211354000Disposable Synthetic Vinyl Nitrile Examination GloveJiangsu Cureguard Glove Co., Ltd.2021-08-08LYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938275200778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938275200778069382752007786938275200778

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
527942388
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938275200686CureguardXS2026-03-30
06938275200693CureguardS2026-03-30
06938275200723CureguardXL2026-03-30
06938275200730CureguardM2026-03-30
06938275200747CureguardL2026-03-30
06938275200754CureguardXS2026-03-30
06938275200761CureguardS2026-03-30
06938275200785CureguardXL2026-03-30
06938275200792CureguardM2026-03-30
06938275200815CureguardXS2026-03-30
06938275200822CureguardS2026-03-30
06938275200839CureguardM2026-03-30
06938275200846CureguardL2026-03-30
06938275200853CureguardXL2026-03-30
06938275200372CureguardS2021-05-26
06938275200389CureguardM2021-05-26
06938275200396CureguardL2021-05-26
06938275200402CureguardXL2021-05-26
06938275200365CureguardXS2021-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00713733712835MeijerMEIJER, INC.LYZ2026-06-05
10840330701911ProCureTwin Med, LLCLYZ2026-05-27
10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27
10840330701959ProCureTwin Med, LLCLYZ2026-05-27
10840330701966ProCureTwin Med, LLCLYZ2026-05-27
10840330701973ProCureTwin Med, LLCLYZ2026-05-27
10840330701980ProCureTwin Med, LLCLYZ2026-05-27
10840330701997ProCureTwin Med, LLCLYZ2026-05-27
10840330702253ProCureTwin Med, LLCLYZ2026-05-27
10840330702260ProCureTwin Med, LLCLYZ2026-05-27
10840330702277ProCureTwin Med, LLCLYZ2026-05-27
10840330702284ProCureTwin Med, LLCLYZ2026-05-27
10840330705162ProCureTwin Med, LLCLYZ2026-05-27
10840330705179ProCureTwin Med, LLCLYZ2026-05-27
10840330705186ProCureTwin Med, LLCLYZ2026-05-27
10840330705193ProCureTwin Med, LLCLYZ2026-05-27
10840330705209ProCureTwin Med, LLCLYZ2026-05-27
10840330705216ProCureTwin Med, LLCLYZ2026-05-27
10840330705223ProCureTwin Med, LLCLYZ2026-05-27
10840330705230ProCureTwin Med, LLCLYZ2026-05-27
20193489081562MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081586MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081593MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
10889483584446AirLife™AIRLIFELYZ2025-02-14
20197344098184SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-27
20197344098160SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098177SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098191SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26