The following data is part of a premarket notification filed by Brightway Holdings Sdn. Bhd. with the FDA for Brightway Brand Nitrile Examination Glove (powder Free, Black Colour).
| Device ID | K060402 |
| 510k Number | K060402 |
| Device Name: | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) |
| 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 | 2006-02-15 |
| Decision Date | 2006-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854947005683 | K060402 | 000 |
| 10850020014344 | K060402 | 000 |
| 10850020014320 | K060402 | 000 |
| 10850019992189 | K060402 | 000 |
| 10850019992165 | K060402 | 000 |
| 10850019992141 | K060402 | 000 |
| 10850019922124 | K060402 | 000 |
| 10850019992103 | K060402 | 000 |
| 10850019992080 | K060402 | 000 |
| 10850018123126 | K060402 | 000 |
| 10850018123102 | K060402 | 000 |
| 10850018123089 | K060402 | 000 |
| 10850018123065 | K060402 | 000 |
| 10850018123041 | K060402 | 000 |
| 10850020014368 | K060402 | 000 |
| 10850020014382 | K060402 | 000 |
| 10854947005669 | K060402 | 000 |
| 10854947005645 | K060402 | 000 |
| 10854947005621 | K060402 | 000 |
| 10854947005607 | K060402 | 000 |
| 10854947005584 | K060402 | 000 |
| 10850020255709 | K060402 | 000 |
| 10850020255686 | K060402 | 000 |
| 10850020255662 | K060402 | 000 |
| 10850020255648 | K060402 | 000 |
| 10850020255624 | K060402 | 000 |
| 10850020255600 | K060402 | 000 |
| 10850020014429 | K060402 | 000 |
| 10850020014405 | K060402 | 000 |
| 10850018123027 | K060402 | 000 |