The following data is part of a premarket notification filed by Brightsway Holdings Sdn Bhd with the FDA for Brightway Brand Blue Color Latex Examination Glove, Powdered Containing 150 Mlgm Or Less Of Water Extractable Protein Pe.
| Device ID | K991752 |
| 510k Number | K991752 |
| Device Name: | BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE |
| Classification | Latex Patient Examination Glove |
| Applicant | BRIGHTSWAY HOLDINGS SDN BHD BATU BELAH Klang Selangor Darul Ehsan, MY 42100 |
| Contact | G. Baskaran |
| Correspondent | G. Baskaran BRIGHTSWAY HOLDINGS SDN BHD BATU BELAH Klang Selangor Darul Ehsan, 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 | 1999-05-24 |
| Decision Date | 1999-06-23 |