FDA.report

Criterion Nitrile EC

Primary DI
20304040101692
Brand
Criterion Nitrile EC
Company
HENRY SCHEIN, INC.
Model
1126786
Catalog number
1126786
Device description
Criterion Nitrile EC SMALL
Published
2019-05-08
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
LZCPatient examination glove, specialty

Product Code Classifications

CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20304040101692PackageGS110In Commercial Distribution
10304040101695PrimaryGS10
00304040101698Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404010169220304040101692
1030404010169510304040101695
00304040101698003040401016983040401016980304040101698

GMDN Terms

TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00FALSE

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
50
DM exempt
true
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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