FDA.report

Saneck Safety

Primary DI
00705689013234
Brand
Saneck Safety
Company
The Cannon Group, Inc.
Model
40-NEPF-3.5-BK-2XL
Device description
Two-Extra-Large Nitrile 3.5MIL Blue Powder-Free Exam Grade Gloves
Published
2024-03-08
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

Related Records

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00705689013234PackageGS110In Commercial Distribution
00705689010264PrimaryGS10
10705689010261Unit of UseGS10

GMDN Terms

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

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 DIBrandModelCatalogPublished
00705689012909Saneck SafetyNEPF-4-BL-LG2025-01-16
00705689017812Saneck SafetyLEPF-5.5-CR-SM2025-02-12
00705689017836Saneck SafetyLEPF-5.5-CR-MD2025-02-12
00705689017850Saneck SafetyLEPF-5.5-CR-LG2025-02-12
00705689017874Saneck SafetyLEPF-5.5-CR-XL2025-02-12
00705689014705Saneck SafetySEPF-4.3-WH-SM2025-02-06
00705689014729Saneck SafetySEPF-4.3-WH-MD2025-02-06
00705689014743Saneck SafetySEPF-4.3-WH-LG2025-02-06
00705689014767Saneck SafetySEPF-4.3-WH-XL2025-02-06
00705689018079Saneck SafetyUMS030022025-01-28
00705689018093Saneck SafetyUMS030032025-01-28
00705689018116Saneck SafetyUMS030042025-01-28
10705689018120Saneck SafetyUMS030052025-01-28
00705689014309Saneck Safety40-VEPF-4-CL-LG2024-06-20
00705689014323Saneck Safety40-VEPF-4-CL-XL2024-06-20
00705689014422Saneck Safety40-VEPF-4-CL-SM2024-06-20
10705689014450Saneck Safety40-VEPF-4-CL-MD2024-06-20
00705689013227Saneck Safety40-NEPF-3.5-BK-XS2024-03-08
00705689013241Saneck Safety40-NEPF-4-BL-XS2024-03-08
00705689011698Saneck Safety40-NEPF-5-BL-XS2024-03-08

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