FDA.report

PROTEXIS

Primary DI
20885380031981
Brand
PROTEXIS
Company
Cardinal Health 200, LLC
Model
2D72PT90X
Catalog number
2D72PT90X
Device description
Sterile Polyisoprene Powder-Free Surgical Gloves
Published
2018-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KGOSurgeon's gloves

Product Code Classifications

CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885380031981PackageGS150In Commercial Distribution
50885380031982PackageGS14In Commercial Distribution
10885380031984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088538003198120885380031981
5088538003198250885380031982
1088538003198410885380031984

GMDN Terms

TermDefinition
Polyisoprene surgical glove, non-powdered, non-antimicrobialA device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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