The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Comfit Brown, Beaded Surgeon's Gloves (powdered, Hypoallergenic).
| Device ID | K960178 |
| 510k Number | K960178 |
| Device Name: | COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) |
| Classification | Surgeon's Gloves |
| Applicant | WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900 |
| Contact | Yue Wah Chow |
| Correspondent | Yue Wah Chow WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-05-06 |
| Summary: | summary |