POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM


Device Classification Name

surgeon’s gloves

510(k) Number K030445
Device Name POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM
Applicant
PRIMUS GLOVES PRIVATE LTD.
14-a, cochin special economic
zone
kakkanad, cochin, kerala, 

IN

682037

Applicant Contact joseph j.e. pereira
Correspondent
PRIMUS GLOVES PRIVATE LTD.
14-a, cochin special economic
zone
kakkanad, cochin, kerala, 

IN

682037

Correspodent Contact joseph j.e. pereira
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 02/11/2003
Decision Date 06/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No