The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove Coated With Cucumber With Glycerine (blue Color).
| Device ID | K060726 |
| 510k Number | K060726 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR) |
| Classification | Polymer Patient Examination Glove |
| Applicant | SMART GLOVE CORP. SDN BHD BATU 5 3/4, JALAN KAPAR KLANG Selangor Darul Eshan, MY 42100 |
| Contact | Cho Sow Fong |
| Correspondent | Cho Sow Fong SMART GLOVE CORP. SDN BHD BATU 5 3/4, JALAN KAPAR KLANG Selangor Darul Eshan, 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 | 2006-03-17 |
| Decision Date | 2006-05-25 |