The following data is part of a premarket notification filed by Brightway Holdings Sdn. Bhd. with the FDA for Brightway Brand Nitrile Surgical Gloves - Sterile (powdered).
| Device ID | K991940 |
| 510k Number | K991940 |
| Device Name: | BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-09 |
| Decision Date | 1999-07-12 |