Last synced on 30 May 2025 at 11:05 pm

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001190
510(k) Type
Traditional
Applicant
KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/23/2000
Days to Decision
41 days
Submission Type
Statement

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001190
510(k) Type
Traditional
Applicant
KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/23/2000
Days to Decision
41 days
Submission Type
Statement