Last synced on 27 June 2025 at 11:06 pm

Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191800
510(k) Type
Traditional
Applicant
Kossan International Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
9/16/2019
Days to Decision
75 days
Submission Type
Statement

Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191800
510(k) Type
Traditional
Applicant
Kossan International Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
9/16/2019
Days to Decision
75 days
Submission Type
Statement