SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE


Device Classification Name

latex patient examination glove

510(k) Number K111923
Device Name SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Applicant
PT. INTAN HEVEA INDUSTRY
jl. pulau irian (kawasan ind.
medan), jl. kom laut yos
sudarso km. 10,5, medan, 

ID

20242

Applicant Contact darwin tandjo
Correspondent
PT. INTAN HEVEA INDUSTRY
jl. pulau irian (kawasan ind.
medan), jl. kom laut yos
sudarso km. 10,5, medan, 

ID

20242

Correspodent Contact darwin tandjo
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 07/07/2011
Decision Date 11/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No