The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Sterile Powder Free Latex Examination Gloves With Protein Claim Less Than 50u/g Of Gloves.
| Device ID | K021521 |
| 510k Number | K021521 |
| Device Name: | STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-10 |
| Decision Date | 2002-07-02 |