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GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193121
510(k) Type
Traditional
Applicant
ECO Medi Glove SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
3/20/2020
Days to Decision
129 days
Submission Type
Summary

GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193121
510(k) Type
Traditional
Applicant
ECO Medi Glove SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
3/20/2020
Days to Decision
129 days
Submission Type
Summary