FDA.reportPublic FDA data

M TRACK

Primary DI
16975390736734
Brand
M TRACK
Company
Guangdong KINGFA SCI.&TECH. Co., Ltd.
Model
KG-1303
Device description
nitrile exam gloves medium size
Published
2023-02-10
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
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213040000Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy DrugsGuangdong Kingfa Sci. & Tech.Co., Ltd.2022-04-27LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26975390736731PackageGS110In Commercial Distribution
16975390736734PrimaryGS10
06975390736737Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697539073673126975390736731
1697539073673416975390736734
06975390736737069753907367376975390736737

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
543265548
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16976739561918AURAKG-1801(GNM-XM)2024-08-09
16976739561925AURAKG-1801(GNL-XM)2024-08-09
16976739561932AURAKG-1801(GNXL-XM)2024-08-09
16976739561901AURAKG-1801(GNS-XM)2024-08-09
06976739561911AURAKG-1801(GNM-XM)2024-08-09
26976739561922AURAKG-1801(GNL-XM)2024-08-09
26976739561939AURAKG-1801(GNXL-XM)2024-08-09
16975390737717MAADHOKG-11012023-03-16
26975390737714MAADHOKG-11012023-03-16
16975390734976KINGFAKG-13032023-02-14
16975390735010KINGFAKG-13032023-02-14
26975390734973KINGFAKG-13032023-02-14
26975390735017KINGFAKG-13032023-02-14
16975390736727M TRACKKG-13032023-02-10
16975390736741M TRACKKG-13032023-02-10
16975390736758M TRACKKG-13032023-02-10
26975390736724M TRACKKG-13032023-02-10
26975390736731M TRACKKG-13032023-02-10
26975390736748M TRACKKG-13032023-02-10
26975390736755M TRACKKG-13032023-02-10

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Primary DI, Brand, Company table
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