Last synced on 30 May 2025 at 11:05 pm

STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K012856
510(k) Type
Traditional
Applicant
SMART GLOVE CORP. SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/16/2001
Days to Decision
84 days
Submission Type
Statement

STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K012856
510(k) Type
Traditional
Applicant
SMART GLOVE CORP. SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
11/16/2001
Days to Decision
84 days
Submission Type
Statement