The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Comfit Powder Free Green Examination Gloves (hypoallergenic, Low Protein).
| Device ID | K962189 |
| 510k Number | K962189 |
| Device Name: | COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) |
| Classification | Latex 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 | 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-06 |
| Decision Date | 1996-07-26 |
| Summary: | summary |