Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K010077
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K010077
Device Name
Polymer Patient Examination Glove
Applicant
PWA INDUSTRIES SDN. BHD.
LOT 93, SEMAMBU INDUST. ESTATE
KUANTAN, PAHANG 25350 MY
Other 510(k) Applications for this Company
Contact
K. KARUNAKARAN
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2001
Decision Date
02/28/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact