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, [sterling/grey] Tested For Use With Chemotherapy Drugs.
| Device ID | K161215 |
| 510k Number | K161215 |
| Device Name: | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] 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 | 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 | 2016-04-29 |
| Decision Date | 2016-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036000507093 | K161215 | 000 |
| 10036000507086 | K161215 | 000 |
| 10036000507079 | K161215 | 000 |
| 10036000507062 | K161215 | 000 |
| 10036000507055 | K161215 | 000 |