FDA.report

Criterion PC Glove PF Latex

Primary DI
20304040102149
Brand
Criterion PC Glove PF Latex
Company
HENRY SCHEIN, INC.
Model
1025421
Catalog number
1025421
Device description
Criterion PC Glove PF Latex Medium
Published
2020-01-08
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
LYYLatex patient examination glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20304040102149PackageGS110In Commercial Distribution
10304040102142PrimaryGS10
00304040102145Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404010214920304040102149
1030404010214210304040102142
00304040102145003040401021453040401021450304040102145

GMDN Terms

TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-sterileA non-sterile device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00FALSE

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
100
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
true
No natural rubber latex
false
Sterilization required before use
false

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