Last synced on 27 June 2025 at 11:06 pm

Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223903
510(k) Type
Special
Applicant
Semperit Investments Asia PTE LTD.
Country
Singapore
FDA Decision
Substantially Equivalent
Decision Date
1/27/2023
Days to Decision
30 days
Submission Type
Summary

Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223903
510(k) Type
Special
Applicant
Semperit Investments Asia PTE LTD.
Country
Singapore
FDA Decision
Substantially Equivalent
Decision Date
1/27/2023
Days to Decision
30 days
Submission Type
Summary