Mia Secret

Primary DI
00842342116533
Brand
Mia Secret
Company
MIA SECRET
Model
NGS-1205
Published
2023-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K133307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133307000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842342116687PackageGS110In Commercial Distribution
00842342116533PrimaryGS10
30842342116534Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842342116687008423421166878423421166870842342116687
00842342116533008423421165338423421165330842342116533
3084234211653430842342116534

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.

Regulatory Flags#

DUNS number
118924410
Device count
100
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842342116540Mia SecretNGM-12102023-03-07
00842342116557Mia SecretNGL-12152023-03-07
00842342116564Mia SecretNGXL-12202023-03-07
00842342116687Mia SecretNGS-12052023-03-07
00842342116694Mia SecretNGM-12102023-03-07
00842342116700Mia SecretNGL-12152023-03-07
00842342116717Mia SecretNGXL-12202023-03-07

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Primary DI, Brand, Company table
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