FDA.reportPublic FDA data

Kashi Scientific

Primary DI
00850039389085
Brand
Kashi Scientific
Company
Kashi Scientific, LLC
Model
2201
Catalog number
103C-M
Device description
Powder-Free Nitrile Examination Gloves - Non Latex - Medium(M)
Published
2022-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850039389092PackageGS110In Commercial Distribution
00850039389085PrimaryGS10
00850039389078Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850039389092008500393890928500393890920850039389092
00850039389085008500393890858500393890850850039389085
00850039389078008500393890788500393890780850039389078

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850039389023Kashi Scientific2201103C-XS2022-01-30
00850039389054Kashi Scientific2201103C-S2022-01-30
00850039389115Kashi Scientific2201103C-L2022-01-30
00850039389139Kashi Scientific2201103C-XL2022-01-30
00850039389153Kashi Scientific2207106A02022-07-14
00850039389160Kashi Scientific2207106A02022-07-14
00860008024459Kashi Scientific2112106C02022-01-01
00850039389030Kashi Scientific2201103C-XS2022-01-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
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