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Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230875
510(k) Type
Traditional
Applicant
Central Medicare Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
7/20/2023
Days to Decision
112 days
Submission Type
Statement

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230875
510(k) Type
Traditional
Applicant
Central Medicare Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
7/20/2023
Days to Decision
112 days
Submission Type
Statement