FDA.reportPublic FDA data

Saneck Safety

Primary DI
00705689018079
Brand
Saneck Safety
Company
The Cannon Group, Inc.
Model
UMS03002
Device description
Small Vinyl 4MIL Clear Powder-Free Exam Grade Gloves
Published
2025-01-28
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
K210780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210780000Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)Shandong Shangwei Medical Products Co., Ltd.2021-05-14LYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00705689018079PackageGS110In Commercial Distribution
00705689018062PrimaryGS10
10705689018069Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00705689018079007056890180797056890180790705689018079
00705689018062007056890180627056890180620705689018062
1070568901806910705689018069

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
131884975
Device count
150
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00705689011032Saneck SafetyNEPF-6-OR-2XL2024-01-25
00705689011049Saneck SafetyNEPF-6-OR-LG2024-01-25
00705689011056Saneck SafetyNEPF-6-OR-MD2024-01-25
00705689011063Saneck SafetyNEPF-6-OR-SM2024-01-25
00705689011070Saneck SafetyNEPF-6-OR-XL2024-01-25
00705689010271Saneck SafetyNEPF-4-BL-XS2024-03-08
00705689010295Saneck SafetyNEPF-4-BL-MD2024-01-29
00705689010301Saneck SafetyNEPF-4-BL-LG2025-01-16
00705689010318Saneck SafetyNEPF-4-BL-XL2024-01-29
00705689010325Saneck SafetyNEPF-4-BL-2XL2024-01-29
00705689010455Saneck SafetyNEPF-6-BL-XS2024-01-25
00705689010462Saneck SafetyNEPF-6-BL-SM2024-01-29
00705689010479Saneck SafetyNEPF-6-BL-MD2024-01-29
00705689010486Saneck SafetyNEPF-6-BL-LG2024-01-29
00705689010493Saneck SafetyNEPF-6-BL-XL2024-01-29
00705689010509Saneck SafetyNEPF-6-BL-2XL2024-01-29
00705689010516Saneck SafetyNEPF-7-BK-XS2024-01-26
00705689010523Saneck SafetyNEPF-7-BK-SM2024-01-26
00705689010530Saneck SafetyNEPF-7-BK-MD2024-01-26
00705689010547Saneck SafetyNEPF-7-BK-LG2024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10860011916618Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19