The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Aloetouch Powder Free Latex Surgical Gloves, Sterile, Coated With Aloe Vera And With Protein Content Labeling Claim (50.
| Device ID | K032464 |
| 510k Number | K032464 |
| Device Name: | ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50 |
| Classification | Surgeon's Gloves |
| Applicant | WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900 |
| Contact | Terence Lim |
| Correspondent | Terence Lim WRP ASIA PACIFIC 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-11 |
| Decision Date | 2003-08-22 |
| Summary: | summary |