The following data is part of a premarket notification filed by Brightway Holdings Sdn. Bhd. with the FDA for Nitrile Examination Gloves, Powder Free [purple] Tested For Use With Chemotherapy Drugs.
| Device ID | K170686 |
| 510k Number | K170686 |
| Device Name: | Nitrile Examination Gloves, Powder Free [Purple] Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah Klang, MY 42100 |
| Contact | G. Baskaran |
| Correspondent | Wava Truscott Truscott MedSci Associates, LLC 180 Burkemeade Ct Roswell, GA 30075 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-07 |
| Decision Date | 2017-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036000550846 | K170686 | 000 |
| 10036000550839 | K170686 | 000 |
| 10036000550822 | K170686 | 000 |
| 10036000550815 | K170686 | 000 |
| 10036000550808 | K170686 | 000 |