FDA.reportPublic FDA data

Sahura

Primary DI
00860008128607
Brand
Sahura
Company
SAHURA INC.
Model
Palmova
Device description
Nitrile Gloves (Size XS) Box of 200
Published
2022-02-04
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008128607PrimaryGS10
00860008128652Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008128607008600081286078600081286070860008128607
00860008128652008600081286528600081286520860008128652

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
118516976
Device count
200
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008128614Sahura Palmova 2022-02-04
00860008128621Sahura Palmova 2022-02-04
00860008128638Sahura Palmova 2022-02-04
00860008128645Sahura Palmova 2022-02-04
00860008128652SahuraPalmova 2022-02-04
00860008128669Sahura Palmova 2022-02-04
00860008128676Sahura Palmova 2022-02-04
00860008128683Sahura Palmova 2022-02-04
00860008128690Sahura Palmova 2022-02-04

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Primary DI, Brand, Company table
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