Search Results
Found 3 results
510(k) Data Aggregation
K Number
K230314Device Name
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
Manufacturer
New Era Medicare Sdn. Bhd.
Date Cleared
2023-08-16
(191 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
New Era Medicare Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Powder Free Nittile Examination Gloves (Blue, Black and White Colors) is a disposable device intended for medical purposed that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
Ask a Question
K Number
K221424Device Name
Sterile Surgical Powder Free Latex Glove
Manufacturer
New Era Medicare Sdn. Bhd.
Date Cleared
2023-01-26
(255 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
New Era Medicare Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Surgical Powder Free Latex Glove is a disposable device intended for medical purposed that is worn on by operating room personnel to protect a surgical wound from contamination.
Device Description
Sterile Surgical Powder Free Latex Glove
Ask a Question
K Number
K221667Device Name
Non Sterile Powder Free Latex Examination Glove
Manufacturer
New Era Medicare Sdn. Bhd.
Date Cleared
2022-10-28
(142 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
New Era Medicare Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non Sterile Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Non Sterile Powder Free Latex Examination Gloves
Ask a Question
Page 1 of 1