Last synced on 27 June 2025 at 11:06 pm

Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220215
510(k) Type
Traditional
Applicant
KSG MEDICARE Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
3/26/2022
Days to Decision
59 days
Submission Type
Statement

Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220215
510(k) Type
Traditional
Applicant
KSG MEDICARE Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
3/26/2022
Days to Decision
59 days
Submission Type
Statement