The following data is part of a premarket notification filed by Brightsway Holdings Sdn Bhd with the FDA for Brightway Brand Latex Surgical Gloves - Sterile (powder Free).
| Device ID | K992021 |
| 510k Number | K992021 |
| Device Name: | BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE) |
| Classification | Surgeon's Gloves |
| Applicant | BRIGHTSWAY HOLDINGS SDN BHD LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, Selangor, MY 42100 |
| Contact | G. Baskaran |
| Correspondent | G. Baskaran BRIGHTSWAY HOLDINGS SDN BHD LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, Selangor, MY 42100 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-16 |
| Decision Date | 1999-07-23 |