FDA.reportPublic FDA data

Saneck Safety

Primary DI
00705689010226
Brand
Saneck Safety
Company
The Cannon Group, Inc.
Model
NEPF-3.5-BK-SM
Device description
SMALL NITRILE 3.5MIL BLACK POWDER-FREE EXAM GRADE GLOVES - PLEASE REFER TO UPDATED UDI INFORMATION
Published
2024-01-09
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705689010223PackageGS110Not in Commercial Distribution
00705689010226PrimaryGS10
20705689010220Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070568901022310705689010223
00705689010226007056890102267056890102260705689010226
2070568901022020705689010220

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
131884975
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01