Last synced on 25 January 2026 at 3:41 am

LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011407
510(k) Type
Traditional
Applicant
Sempermed USA, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/11/2001
Days to Decision
145 days
Submission Type
Summary

LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011407
510(k) Type
Traditional
Applicant
Sempermed USA, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/11/2001
Days to Decision
145 days
Submission Type
Summary