The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Profeel Powder Free Surgical Gloves (protein Content Labeling).
| Device ID | K972621 |
| 510k Number | K972621 |
| Device Name: | PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) |
| 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 | Chow Yue Wah |
| Correspondent | Chow Yue Wah 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 | 1997-07-14 |
| Decision Date | 1997-10-24 |
| Summary: | summary |