The following data is part of a premarket notification filed by Brightway Holdings Sdn. Bhd. with the FDA for Brightway Brand Colored Powder Free Nitrile Examination Gloves (orange).
| Device ID | K022878 |
| 510k Number | K022878 |
| Device Name: | BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | BRIGHTWAY HOLDINGS SDN. BHD. LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, Selangor, MY 42100 |
| Contact | G. Baskaran |
| Correspondent | G. Baskaran BRIGHTWAY HOLDINGS SDN. BHD. LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, Selangor, 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 | 2002-08-30 |
| Decision Date | 2002-09-17 |