FDA.reportPublic FDA data

Alasta® White

Primary DI
00649531910145
Brand
Alasta® White
Company
Dash Medical Gloves, Inc.
Model
AW100M
Device description
Nitrile Exam Glove, White, Medium
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00649531910145PackageGS110In Commercial Distribution
00649531900146PrimaryGS10
00649531900047Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00649531910145006495319101456495319101450649531910145
00649531900146006495319001466495319001460649531900146
00649531900047006495319000476495319000470649531900047

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
414-269-5298compliancedepartment@dashmedical.com

Regulatory Flags#

DUNS number
194914768
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00649531042228Black Maxx® Extreme NitrileBMNE100S2025-09-09
00649531042242Black Maxx® Extreme NitrileBMNE100M2025-09-09
00649531042266Black Maxx® Extreme NitrileBMNE100L2025-09-09
00649531042273Black Maxx® Extreme NitrileBMNE100XL2025-09-09
00649531042280Black Maxx® Extreme NitrileBMNE100XXL2025-09-09
00649531202110Alasta® PROALGA200XS2025-09-09
00649531202127Alasta® PROALGA200S2025-09-09
00649531202141Alasta® PROALGA200M2025-09-09
00649531202165Alasta® PROALGA200L2025-09-09
00649531202172Alasta® PROALGA200XL2025-09-09
00649531202189Alasta® PROALGA200XXL2025-09-09
00649531596714FLEX100™FLEX100XS2025-09-09
00649531596721FLEX100™FLEX100S2025-09-09
00649531596745FLEX100™FLEX100M2025-09-09
00649531596769FLEX100™FLEX100L2025-09-09
00649531596776FLEX100™FLEX100XL2025-09-09
00649531596783FLEX100™FLEX100XXL2025-09-09
00649531596110FLEX200™FLEX200XS2023-10-06
00649531596127FLEX200™FLEX200S2023-10-06
00649531596141FLEX200™FLEX200M2023-10-06

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