The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Sterile Powder Free Latex Surgical Gloves With Protein Claim Less Than 50 Ug/g.
| Device ID | K013727 |
| 510k Number | K013727 |
| Device Name: | STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-09 |
| Decision Date | 2001-12-07 |