Last synced on 25 January 2026 at 3:41 am

AT

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212645
510(k) Type
Traditional
Applicant
At Glove Engineering Sdn. Bhd
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
12/16/2021
Days to Decision
118 days
Submission Type
Summary

AT

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212645
510(k) Type
Traditional
Applicant
At Glove Engineering Sdn. Bhd
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
12/16/2021
Days to Decision
118 days
Submission Type
Summary