FDA.report

HCS

Primary DI
10810132040488
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
HCS5503
Device description
Stretch Vinyl Examination Gloves, Powder-Free, DINP/DOP/DEHP Free, Non-Sterile, X-Large
Published
2023-05-01
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
LYZVinyl Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810132040488PackageGS110In Commercial Distribution
00810132040481PrimaryGS10
20810132040485Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013204048810810132040488
00810132040481008101320404818101320404810810132040481
2081013204048520810132040485

GMDN Terms

TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
080220245
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

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