The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Profeel Synthetic Copolymer Surgical Gloves (powdered).
| Device ID | K982600 |
| 510k Number | K982600 |
| Device Name: | PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) |
| Classification | Surgeon's Gloves |
| Applicant | WEMBLEY RUBBER PRODUCTS (M) SDN BHD PERU BANDAR BARU SALAK TINGGI 43900 SEPANG Selangor, Malaysia, MY |
| Contact | Chow Yue Wah |
| Correspondent | Chow Yue Wah WEMBLEY RUBBER PRODUCTS (M) SDN BHD PERU BANDAR BARU SALAK TINGGI 43900 SEPANG Selangor, Malaysia, MY |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-27 |
| Decision Date | 1999-03-12 |
| Summary: | summary |