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AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211310
510(k) Type
Traditional
Applicant
Megine Industries Sdn Bhd
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
6/16/2021
Days to Decision
47 days
Submission Type
Summary

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211310
510(k) Type
Traditional
Applicant
Megine Industries Sdn Bhd
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
6/16/2021
Days to Decision
47 days
Submission Type
Summary