Last synced on 11 July 2025 at 11:06 pm

X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K010961
510(k) Type
Special
Applicant
ANSELL HEALTHCARE PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/31/2001
Days to Decision
62 days
Submission Type
Summary

X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K010961
510(k) Type
Special
Applicant
ANSELL HEALTHCARE PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/31/2001
Days to Decision
62 days
Submission Type
Summary