FDA.report

Nuvo™

Primary DI
00649531242048
Brand
Nuvo™
Company
Dash Medical Gloves, Inc.
Model
NV100M
Device description
Vinyl 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

Related Records

Contact Domains

Product Codes

CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00649531242048PackageGS110In Commercial Distribution
00649531990024PrimaryGS10
00649531990123Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00649531242048006495312420486495312420480649531242048
00649531990024006495319900246495319900240649531990024
00649531990123006495319901236495319901230649531990123

GMDN Terms

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

Contacts

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

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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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