The following data is part of a premarket notification filed by Brightway Holdings Sdn Bhd. with the FDA for Brightway Brand Nitrile Examination Gloves, Powder Free (lavender).
| Device ID | K162146 |
| 510k Number | K162146 |
| Device Name: | Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) |
| Classification | Polymer Patient Examination Glove |
| Applicant | BRIGHTWAY HOLDINGS SDN BHD. LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, MY 42100 |
| Contact | G. Baskaran |
| Correspondent | G. Baskaran BRIGHTWAY HOLDINGS SDN BHD. LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, 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 | 2016-08-01 |
| Decision Date | 2017-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036007528169 | K162146 | 000 |
| 10036000528173 | K162146 | 000 |
| 10036000528180 | K162146 | 000 |
| 10036000528197 | K162146 | 000 |
| 10036000528203 | K162146 | 000 |
| 10036003528194 | K162146 | 000 |
| 10036004528186 | K162146 | 000 |
| 10036005528178 | K162146 | 000 |
| 10036006528207 | K162146 | 000 |
| 10036000528166 | K162146 | 000 |