FDA.reportPublic FDA data

CUSTOMED

Primary DI
M20890030517
Brand
CUSTOMED
Company
CUSTOMED INC
Model
712057693051
Catalog number
9003051
Device description
CUSTOMFEEL LATEX POWDERED SURGICAL GLOVE 8
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010198000STERILE POWDERED LATEX SURGEON GLOVESSupermax Glove Manufacturing Sdn Bhd2001-02-23KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20890030511PackageHIBCC50In Commercial Distribution
M20890030512PackageHIBCC5In Commercial Distribution
M20890030517PrimaryHIBCC0
M20890030510Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, powderedA 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 site; its inner surface is covered with talcum powder primarily to facilitate donning and removal; 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 contamination from microorganisms. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference8Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid Ozone.
Special Storage Condition, Specify00Store in Cool Dry Place.

Contacts#

Phone, Email table
PhoneEmail
787-622-5151customer.service@customedhealing.com

Regulatory Flags#

DUNS number
627572217
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M2089004048C1CUSTOMED7120577000489004048C2023-08-10
M2089004049C1CUSTOMED7120577000499004049C2023-08-10
M2089004050C1CUSTOMED7120577000509004050C2023-08-10
M2089004051C1CUSTOMED7120577000519004051C2023-08-10
M20810063642CUSTOMEDOR TURNOVER DRAPE WITH TRANSFER SHEET10063642023-08-10
M20890029842CUSTOMED71205710298490029842023-08-10
M20890029852CUSTOMED71205710298590029852023-08-10
M20890029862CUSTOMED71205710298690029862023-08-10
M20890029872CUSTOMED71205710298790029872023-08-10
M20890029882CUSTOMED71205710298890029882023-08-10
M20890030922CUSTOMED71205710309290030922023-08-10
M20890030932CUSTOMED71205710309390030932023-08-10
M20890031442CUSTOMED71205710314490031442023-08-10
M20890040522CUSTOMED71205710405290040522023-08-10
M20890046941CUSTOMED71205701469490046942023-08-10
M20890046951CUSTOMED71205701469590046952023-08-10
M20810063640CUSTOMEDOR TURNOVER DRAPE WITH TRANSFER SHEET10063642023-08-10
M20890029840CUSTOMED71205710298490029842023-08-10
M20890029850CUSTOMED71205710298590029852023-08-10
M20890029860CUSTOMED71205710298690029862023-08-10

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