FDA.report

Latex Exam XS PF Txt Gloves (100)

Primary DI
00815878021992
Brand
Latex Exam XS PF Txt Gloves (100)
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72720616
Published
2019-04-24
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
00815878021992PackageGS1100In Commercial Distribution
00815878021947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815878021992008158780219928158780219920815878021992
00815878021947008158780219478158780219470815878021947

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
027532357
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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00810052610313Burkhart Dental Supply727218412024-01-15
00810052610320Burkhart Dental Supply727218422024-01-15
00810052610337Burkhart Dental Supply727218432024-01-15

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