FDA.reportPublic FDA data

Saneck Safety

Primary DI
00705689010301
Brand
Saneck Safety
Company
The Cannon Group, Inc.
Model
NEPF-4-BL-LG
Device description
Large Nitrile 4MIL Blue Powder-Free Exam Grade Gloves
Published
2025-01-16
Public version status
Update
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
LZCMedical Glove, Specialty
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00705689012909PackageGS110In Commercial Distribution
00705689010301PrimaryGS10
10705689010308Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00705689012909007056890129097056890129090705689012909
00705689010301007056890103017056890103010705689010301
1070568901030810705689010308

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
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
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
00705689010554Saneck SafetyNEPF-7-BK-XL2024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536747Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536754Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
08994452290022Nitrile Examination Gloves Powder FreePT. SINTONG UNIGOLDEN GLOVELZC2024-02-26