FDA.reportPublic FDA data

Gen-X®

Primary DI
09551005270666
Brand
Gen-X®
Company
SMART GLOVE INTERNATIONAL PTE. LTD.
Model
CPFEMD
Device description
Polychloroprene C-series Examination Gloves, Powder Free - S
Published
2023-10-31
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
19551005270663PackageGS110In Commercial Distribution
09551005270666PrimaryGS10
29551005270660Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955100527066319551005270663
09551005270666095510052706669551005270666
2955100527066029551005270660

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA device made of polychloroprene (neoprene) 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Regulatory Flags#

DUNS number
659506974
Device count
100
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
09551005270192Gen-X®LPFEMD2023-10-31
09551005270208Gen-X®LPFEMD2023-10-31
09551005270215Gen-X®LPFEMD2023-10-31
09551005270222Gen-X®LPFEMD2023-10-31
09551005270239Gen-X®LPFEMD2023-10-31
09551005270246Gen-X®LPFEMD2023-10-31
09551005270253Gen-X®LPFEMD2023-10-31
09551005270123Gen-X®NPFEMD2023-10-31
09551005270130Gen-X®NPFEMD2023-10-31
09551005270147Gen-X®NPFEMD2023-10-31
09551005270154Gen-X®NPFEMD2023-10-31
09551005270161Gen-X®NPFEMD2023-10-31
09551005270178Gen-X®NPFEMD2023-10-31
09551005270185Gen-X®NPFEMD2023-10-31
09551005270406Gen-X®NPFEMD2023-10-31
09551005270413Gen-X®NPFEMD2023-10-31
09551005270420Gen-X®NPFEMD2023-10-31
09551005270437Gen-X®NPFEMD2023-10-31
09551005270444Gen-X®NPFEMD2023-10-31
09551005270451Gen-X®NPFEMD2023-10-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810141933962VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCLZA2026-10-07
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
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00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
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00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14