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Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180505
510(k) Type
Traditional
Applicant
Hartalega Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
6/14/2018
Days to Decision
108 days
Submission Type
Statement

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180505
510(k) Type
Traditional
Applicant
Hartalega Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
6/14/2018
Days to Decision
108 days
Submission Type
Statement