Kashi Scientific

Primary DI
00850039389030
Brand
Kashi Scientific
Company
Kashi Scientific, LLC
Model
2201
Catalog number
103C-XS
Device description
Powder-Free Nitrile Examination Glove - Non Latex- Extra Small(XS)
Published
2022-01-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003985000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003985000POWDERFREE NITRILE PATIENT EXMINATION GLOVEGuthrie Medicare Products (Melaka) Sdn Bhd2001-02-09LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850039389030PackageGS110In Commercial Distribution
00850039389023PrimaryGS10
00850039389016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850039389030008500393890308500393890300850039389030
00850039389023008500393890238500393890230850039389023
00850039389016008500393890168500393890160850039389016

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile 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 powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius37 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit100 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(888) 280 1126info@kashiscientific.com

Regulatory Flags#

DUNS number
110618994
Device count
100
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850039389023Kashi Scientific2201103C-XS2022-01-30
00850039389054Kashi Scientific2201103C-S2022-01-30
00850039389085Kashi Scientific2201103C-M2022-01-30
00850039389115Kashi Scientific2201103C-L2022-01-30
00850039389139Kashi Scientific2201103C-XL2022-01-30
00850039389153Kashi Scientific2207106A02022-07-14
00850039389160Kashi Scientific2207106A02022-07-14
00860008024459Kashi Scientific2112106C02022-01-01

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