The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (blue).
| Device ID | K063627 |
| 510k Number | K063627 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 JALAN KAPAR Klang Selangor, MY 42100 |
| Contact | Cho S Fong |
| Correspondent | Cho S Fong SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 JALAN KAPAR Klang Selangor, 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 | 2006-12-06 |
| Decision Date | 2007-03-20 |
| Summary: | summary |