The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Smart Glove Sterile Nitrile Examination Gloves (powdered Free).
| Device ID | K021013 |
| 510k Number | K021013 |
| Device Name: | SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 SEMENTA, JALAN KAPAR Selangor Darul Ehsan, MY 42100 |
| Contact | Ng Yew Soon |
| Correspondent | Ng Yew Soon SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 SEMENTA, JALAN KAPAR Selangor Darul Ehsan, 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 | 2002-03-29 |
| Decision Date | 2002-05-22 |