LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)


Device Classification Name

latex patient examination glove

510(k) Number K111158
Device Name LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
INNOVATIVE GLOVES CO; LTD
830 moo 4 sanambin-banklang rd
kuanlang
hatyai, songkhla, 

TH

90110

Applicant Contact rajeev sood
Correspondent
INNOVATIVE GLOVES CO; LTD
830 moo 4 sanambin-banklang rd
kuanlang
hatyai, songkhla, 

TH

90110

Correspodent Contact rajeev sood
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 04/25/2011
Decision Date 08/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No