The following data is part of a premarket notification filed by Brightway Holdings Sdn. Bhd. with the FDA for Brightway Brand Latex Examination Gloves (powder Free).
| Device ID | K990539 |
| 510k Number | K990539 |
| Device Name: | BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-22 |
| Decision Date | 1999-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850022371339 | K990539 | 000 |
| 10036000434320 | K990539 | 000 |
| 10036000434337 | K990539 | 000 |
| 10036000434344 | K990539 | 000 |
| 10036000434351 | K990539 | 000 |
| 10036000434368 | K990539 | 000 |
| 10036000505013 | K990539 | 000 |
| 10036000505020 | K990539 | 000 |
| 10036000505037 | K990539 | 000 |
| 10036000505044 | K990539 | 000 |
| 10036000571100 | K990539 | 000 |
| 10036000572206 | K990539 | 000 |
| 10036000573302 | K990539 | 000 |
| 10036000574408 | K990539 | 000 |
| 10036000575504 | K990539 | 000 |
| 10850022371308 | K990539 | 000 |
| 10850022371315 | K990539 | 000 |
| 10850022371322 | K990539 | 000 |
| 10036000434313 | K990539 | 000 |