The following data is part of a premarket notification filed by Brightway Holdings Sdn Bhd. with the FDA for Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [purple] Tested For Use With Chemotherapy Drugs.
| Device ID | K162294 |
| 510k Number | K162294 |
| Device Name: | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, 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, 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 | 2016-08-15 |
| Decision Date | 2017-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036000550907 | K162294 | 000 |
| 10036000506041 | K162294 | 000 |
| 10036000506034 | K162294 | 000 |
| 10036000506027 | K162294 | 000 |
| 10036000506010 | K162294 | 000 |