The following data is part of a premarket notification filed by Brightway Holdings Sdn Bhd with the FDA for Nitrile Examination Glove.
| Device ID | K163267 |
| 510k Number | K163267 |
| Device Name: | NITRILE EXAMINATION GLOVE |
| 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 | 2016-11-21 |
| Decision Date | 2017-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036000505822 | K163267 | 000 |
| 10036000505808 | K163267 | 000 |
| 10036000505785 | K163267 | 000 |
| 10036000505761 | K163267 | 000 |
| 10036000505747 | K163267 | 000 |