The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Scinitrex (powder Free Nitrile Examination Gloves).
| Device ID | K952051 |
| 510k Number | K952051 |
| Device Name: | SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) |
| Classification | Polymer Patient Examination Glove |
| Applicant | WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900 |
| Contact | Ong G Chee |
| Correspondent | Ong G Chee WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1995-12-15 |