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Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180645
510(k) Type
Traditional
Applicant
Hartalega Sdn Bhd
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/16/2018
Days to Decision
249 days
Submission Type
Statement

Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180645
510(k) Type
Traditional
Applicant
Hartalega Sdn Bhd
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/16/2018
Days to Decision
249 days
Submission Type
Statement