Last synced on 27 June 2025 at 11:06 pm

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170397
510(k) Type
Traditional
Applicant
Kossan International Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
7/10/2017
Days to Decision
151 days
Submission Type
Statement

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170397
510(k) Type
Traditional
Applicant
Kossan International Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
7/10/2017
Days to Decision
151 days
Submission Type
Statement