FDA.reportPublic FDA data

Black Maxx® Nitrile

Primary DI
00649531040125
Brand
Black Maxx® Nitrile
Company
Dash Medical Gloves, Inc.
Model
BMN100S
Device description
Nitrile Exam Glove, Black, Small
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00649531140122PackageGS110In Commercial Distribution
00649531040125PrimaryGS10
00649531040026Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00649531140122006495311401226495311401220649531140122
00649531040125006495310401256495310401250649531040125
00649531040026006495310400266495310400260649531040026

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.

Contacts#

Phone, Email table
PhoneEmail
4142695298Compliancedepartment@dashmedical.com

Regulatory Flags#

DUNS number
194914768
Device count
100
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00649531592112GloveUP®GUP300XS2022-09-22
00649531592129GloveUP®GUP300S2022-09-22
00649531592143GloveUP®GUP300M2022-09-22
00649531592167GloveUP®GUP300L2021-05-31
00649531592174GloveUP®GUP300XL2022-09-22
00649531596318FLEX300™FLEX300XS2025-10-23
00649531596325FLEX300™FLEX300S2025-10-23
00649531596349FLEX300™FLEX300M2025-10-23
00649531596363FLEX300™FLEX300L2025-10-23
00649531596370FLEX300™FLEX300XL2025-10-23
00649531596387FLEX300™FLEX300XXL2025-10-23
00649531042129Black Maxx® Extreme NitrileBMNE100S2025-09-09
00649531042143Black Maxx® Extreme NitrileBMNE100M2025-09-09
00649531042167Black Maxx® Extreme NitrileBMNE100L2025-09-09
00649531042174Black Maxx® Extreme NitrileBMNE100XL2025-09-09
00649531042181Black Maxx® Extreme NitrileBMNE100XXL2025-09-09
00649531202011Alasta® PROALGA200XS2025-09-09
00649531202028Alasta® PROALGA200S2025-09-09
00649531202042Alasta® PROALGA200M2025-09-09
00649531202066Alasta® PROALGA200L2025-09-09

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Primary DI, Brand, Company table
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00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
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00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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00842942014154PRIMEDpriMED Medical Products IncLZC2025-11-18
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