The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove (black And Gray).
Device ID | K060724 |
510k Number | K060724 |
Device Name: | POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) |
Classification | Polymer Patient Examination Glove |
Applicant | SMART GLOVE CORP. SDN BHD BATU 5 3/4, JALAN KAPAR KLANG Selangor Darul Eshan, MY 42100 |
Contact | Cho Sow Fong |
Correspondent | Cho Sow Fong SMART GLOVE CORP. SDN BHD BATU 5 3/4, JALAN KAPAR KLANG Selangor Darul Eshan, MY 42100 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-17 |
Decision Date | 2006-05-17 |