The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Smart Glove Sterile Nitrile Exam Glove.
| Device ID | K012853 |
| 510k Number | K012853 |
| Device Name: | SMART GLOVE STERILE NITRILE EXAM GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 JALAN KAPAR Klang Selangor, MY 42100 |
| Contact | Ng Yew Soon |
| Correspondent | Ng Yew Soon 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 | 2001-08-24 |
| Decision Date | 2001-11-16 |