The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Sterile Nitrile Surgical Gloves (powdered).
| Device ID | K012479 |
| 510k Number | K012479 |
| Device Name: | STERILE NITRILE SURGICAL GLOVES (POWDERED) |
| Classification | Surgeon's Gloves |
| Applicant | SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 JALAN KAPAR Klang Selangor, MY 42100 |
| Contact | Foo Khon Pu |
| Correspondent | Foo Khon Pu SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 JALAN KAPAR Klang Selangor, MY 42100 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-02 |
| Decision Date | 2001-09-26 |