Last synced on 30 May 2025 at 11:05 pm

PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002065
510(k) Type
Traditional
Applicant
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/22/2000
Days to Decision
46 days
Submission Type
Statement

PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002065
510(k) Type
Traditional
Applicant
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/22/2000
Days to Decision
46 days
Submission Type
Statement