The following data is part of a premarket notification filed by Flexitech Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Gloves.
| Device ID | K990495 |
| 510k Number | K990495 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | FLEXITECH SDN. BHD. LOT 5071, BATU 5 1/2, JALAN MERU Klang, Selangor, MY 41050 |
| Contact | Kenny H.n. Liew |
| Correspondent | Kenny H.n. Liew FLEXITECH SDN. BHD. LOT 5071, BATU 5 1/2, JALAN MERU Klang, Selangor, MY 41050 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-17 |
| Decision Date | 1999-04-02 |