FDA.report

SKYTEC

Primary DI
05060988802824
Brand
SKYTEC
Company
GLOBUS (SHETLAND) LIMITED
Model
UX509 XXL
Published
2024-01-04
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
05060988802824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060988802824050609888028245060988802824

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
578523318
Device count
1
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
05060988802688SKYTECUX409 XL2024-06-17
05060988802701SKYTECUX409 XXL2024-06-17
05060988802381SKYTECUX209 S2024-01-04
05060988802404SKYTECUX209 M2024-01-04
05060988802428SKYTECUX209 L2024-01-04
05060988802435SKYTECUX209 XL2024-01-04
05060988802466SKYTECUX209 XXL2024-01-04
05060988802480SKYTECUX269 XS2024-01-04
05060988802503SKYTECUX269 S2024-01-04
05060988802527SKYTECUX269 M2024-01-04
05060988802541SKYTECUX269 L2024-01-04
05060988802565SKYTECUX269 XL2024-01-04
05060988802589SKYTECUX269 XXL2024-01-04
05060988802602SKYTECUX409 XS2024-01-04
05060988802626SKYTECUX409 S2024-01-04
05060988802640SKYTECUX409 M2024-01-04
05060988802664SKYTECUX409 L2024-01-04
05060988802725SKYTECUX509 XS2024-01-04
05060988802749SKYTECUX509 S2024-01-04
05060988802763SKYTECUX509 M2024-01-04

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