FDA.reportPublic FDA data

Saneck Safety

Primary DI
00705689012909
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
Rx
false
OTC
false
Sterile
false
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
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131884975
Device count
100
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
00850054870544BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
00662956201063Body Guard[Fastenal CompanyLZA2026-09-30
00662956201285Body Guard[Fastenal CompanyLZA2026-09-30
00662956202558Body GuardFastenal CompanyLZA2026-09-30
00662956203258Body GuardFastenal CompanyLZA2026-09-30
00662956203661BodyguardFastenal CompanyLZA2026-09-30
00662956203760BodyguardFastenal CompanyLZA2026-09-30
00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
00199536900219BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03