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 (blue) Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.
| Device ID | K211816 |
| 510k Number | K211816 |
| Device Name: | Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
| Classification | Polymer Patient Examination Glove |
| Applicant | Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah Klang, MY 42100 |
| Contact | G. Baskaran |
| Correspondent | Ganesh Subramaniam 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 | 2021-06-11 |
| Decision Date | 2022-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850018303464 | K211816 | 000 |
| 20850018303457 | K211816 | 000 |
| 20850018303440 | K211816 | 000 |
| 20850018303433 | K211816 | 000 |
| 10850018303412 | K211816 | 000 |
| 10850018303405 | K211816 | 000 |
| 10850018303399 | K211816 | 000 |
| 10850018303382 | K211816 | 000 |