Last synced on 13 June 2025 at 11:06 pm

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181857
510(k) Type
Traditional
Applicant
Kossan International Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/20/2018
Days to Decision
132 days
Submission Type
Statement

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181857
510(k) Type
Traditional
Applicant
Kossan International Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/20/2018
Days to Decision
132 days
Submission Type
Statement