FDA.report

Sensifree Pink Chloroprn Glove

Primary DI
20304040102293
Brand
Sensifree Pink Chloroprn Glove
Company
HENRY SCHEIN, INC.
Model
1126851
Catalog number
1126851
Device description
Sensifree Pink Chloroprn Glove X-Small
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
LZAPolymer patient examination glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20304040102293PackageGS120In Commercial Distribution
10304040102296PrimaryGS10
00304040102299Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404010229320304040102293
1030404010229610304040102296
00304040102299003040401022993040401022990304040102299

GMDN Terms

TermDefinition
Composite-polymer surgical glove, non-powderedA sterile device made from two or more polymer materials intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. 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.

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
false
No natural rubber latex
false
Sterilization required before use
false

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00304040187616Zirlux920006192000612026-02-04
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00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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