The following data is part of a premarket notification filed by Flexitech Sdn. Bhd. with the FDA for Polymer Coated Powder Free Nitrile Examination Gloves, Blue.
| Device ID | K994416 |
| 510k Number | K994416 |
| Device Name: | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
| Classification | Latex Patient Examination Glove |
| Applicant | FLEXITECH SDN. BHD. LOT 5071, BATU 5 1/2, JALAN MERU Klang, Selangor, MY 41050 |
| Contact | Y. F Hew |
| Correspondent | Y. F Hew FLEXITECH SDN. BHD. LOT 5071, BATU 5 1/2, JALAN MERU Klang, Selangor, MY 41050 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-29 |
| Decision Date | 2000-02-03 |