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Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230314
510(k) Type
Traditional
Applicant
New Era Medicare Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/16/2023
Days to Decision
191 days
Submission Type
Statement

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230314
510(k) Type
Traditional
Applicant
New Era Medicare Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/16/2023
Days to Decision
191 days
Submission Type
Statement