FDA.reportPublic FDA data

NEIL MEDICAL

Primary DI
00850063139151
Brand
NEIL MEDICAL
Company
Neil Medical Group
Model
SV103
Catalog number
SV103
Device description
Stretch Vinyl Powder free Examination gloves
Published
2024-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K122656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122656000POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLORShandong Yifan Plastic Products Co., Ltd.2014-05-06LYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850063139151PackageGS110In Commercial Distribution
00850063139113PrimaryGS10
30850063139114Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063139151008500631391518500631391510850063139151
00850063139113008500631391138500631391130850063139113
3085006313911430850063139114

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122260045
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063139168NEIL MEDICALN100N1002024-08-07
00850063139175NEIL MEDICALN101N1012024-08-07
00850063139182NEIL MEDICALN102N1022024-08-07
00850063139373Neil Medical Group 2001-30ML2025-12-08
00850063139366Neil Medical Group 2001-10ML2025-12-08
00850063139434Neil Medical Group 20122025-12-08
00850063139441Neil Medical Group 20522025-12-08
00850063139458Neil Medical Group 20712025-12-08
00850063139465Neil Medical Group 20612025-12-08
00850063139199NEIL MEDICALN103N1032024-08-07
00850063139519Neil Medical Group 40132025-12-08
00850063139526Neil Medical Group 40122025-12-08
00850063139380Neil Medical Group 2004RED2025-12-08
00850063139397Neil Medical Group 2004PVC2025-12-08
00850063139403Neil Medical Group 2005-16FR2025-12-08
00850063139410Neil Medical Group 2005-18FR2025-12-08
00850063139427Neil Medical Group 2005-14FR2025-12-08
00850063139472Neil Medical Group 10012025-12-08
00850063139489Neil Medical Group 3002025-12-08
00850063139496Neil Medical Group 4024-1000ML2025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840330701928ProCureTwin Med, LLCLYZ2026-05-27
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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
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20197344098184SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-27
20197344098160SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
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20197344098191SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
10860011916618Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19