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Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222129
510(k) Type
Traditional
Applicant
Top Glove Medical (Thailand) Co., Ltd.
Country
Thailand
FDA Decision
Substantially Equivalent
Decision Date
2/10/2023
Days to Decision
207 days
Submission Type
Statement

Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222129
510(k) Type
Traditional
Applicant
Top Glove Medical (Thailand) Co., Ltd.
Country
Thailand
FDA Decision
Substantially Equivalent
Decision Date
2/10/2023
Days to Decision
207 days
Submission Type
Statement