REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)

Device Classification Name

latex patient examination glove

510(k) Number K991677
Device Name REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
Applicant
LONDON INTERNATIONAL GROUP, INC.
p.o. box 8308
2926 columbia highway
dothan, 
AL 
36304

Applicant Contact bradley l pugh
Correspondent
LONDON INTERNATIONAL GROUP, INC.
p.o. box 8308
2926 columbia highway
dothan, 
AL 
36304

Correspodent Contact bradley l pugh
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 05/17/1999
Decision Date 04/12/2000
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