The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Profeel Anatom Surg Gloves (powder Free/hypoaller).
| Device ID | K922515 |
| 510k Number | K922515 |
| Device Name: | PROFEEL ANATOM SURG GLOVES (POWDER FREE/HYPOALLER) |
| 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 | Kuei Choo |
| Correspondent | Kuei Choo 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 | 1992-05-27 |
| Decision Date | 1992-11-25 |