Last synced on 27 June 2025 at 11:06 pm

Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222298
510(k) Type
Traditional
Applicant
Onetexx SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
10/18/2022
Days to Decision
78 days
Submission Type
Statement

Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222298
510(k) Type
Traditional
Applicant
Onetexx SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
10/18/2022
Days to Decision
78 days
Submission Type
Statement