Last synced on 30 May 2025 at 11:05 pm

SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103619
510(k) Type
Traditional
Applicant
SHANDONG BLUE SAIL INNOVATION CO., LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
8/10/2011
Days to Decision
243 days
Submission Type
Statement

SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103619
510(k) Type
Traditional
Applicant
SHANDONG BLUE SAIL INNOVATION CO., LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
8/10/2011
Days to Decision
243 days
Submission Type
Statement