The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Comfit Surgeon's Gloves.
| Device ID | K903446 |
| 510k Number | K903446 |
| Device Name: | COMFIT SURGEON'S GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | WEMBLEY RUBBER PRODUCTS (M) SDN BHD 11TH FLOOR, MENARA APERA ULG 84, JALAN RAJA CHULAN 50200 Kuala Lumpur, Malaysia, MY |
| Contact | Eng Keat |
| Correspondent | Eng Keat WEMBLEY RUBBER PRODUCTS (M) SDN BHD 11TH FLOOR, MENARA APERA ULG 84, JALAN RAJA CHULAN 50200 Kuala Lumpur, 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 | 1990-07-27 |
| Decision Date | 1990-10-01 |