FDA.report

McKesson

Primary DI
00612479216686
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
14-34080
Device description
Confiderm Latex Surgical Gloves CHEMO TESTED size 8
Published
2020-03-31
Public version status
New
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
00612479216686PackageGS15In Commercial Distribution
00612479216679PrimaryGS10
00612479216662Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479216686006124792166866124792166860612479216686
00612479216679006124792166796124792166790612479216679
00612479216662006124792166626124792166620612479216662

GMDN Terms

TermDefinition
Radiation attenuating Hevea-latex surgical/procedural gloveA sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical/procedural site; its inner surface is not powdered and the glove's material matrix contains radiation attenuating material intended to limit wearer exposure to incident radiation (e.g., during fluoroscopy). It is used mainly as a two-way barrier to protect patient and staff from contaminants. It will have appropriate characteristics regarding tactility, and should provide appropriate physical properties (e.g., tensile strength, elasticity) and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
40
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
false
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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00612479185388McKesson70-1121MCK2026-03-11
00612479185395McKesson70-1122MCK2026-03-11
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10612479281582McKesson181-342252026-02-06
00612479278356McKesson16-61442026-01-26
00612479278370McKesson16-61482026-01-26
00612479278387McKesson16-61682026-01-26
00612479278431McKesson16-618102026-01-26

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