FDA.reportPublic FDA data

Nuvo™

Primary DI
00649531242062
Brand
Nuvo™
Company
Dash Medical Gloves, Inc.
Model
NV100L
Device description
Vinyl Exam Glove, White, Large
Published
2021-07-31
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
LYZVinyl Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00649531242062PackageGS110In Commercial Distribution
00649531990031PrimaryGS10
00649531990130Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00649531242062006495312420626495312420620649531242062
00649531990031006495319900316495319900310649531990031
00649531990130006495319901306495319901300649531990130

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
4142695298Compliancedepartment@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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975219206540GcareZibo Blue Sail Innovation Co., Ltd.LYZ2026-05-26
06973022280153Blue SailShandong Blue Sail Innovation Co., Ltd.LYZ2026-05-25
06973022280481Blue SailShandong Blue Sail Innovation Co., Ltd.LYZ2026-05-25
40888277170897MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-03-20
40888277170972MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-03-20
40080196764076MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-25
40080196764083MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-25
40884389102221MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-25
40884389102238MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-25
40080196167952MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
40080196167990MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
40080196168010MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
40888277305350MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
40888277305367MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
40888277305374MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
40888277305381MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
10810206690953BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206690960BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206690977BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691158BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691165BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691172BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691189BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691592BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691608BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691615BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691622BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691639BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691646BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10193489136708MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11