The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated With Aloe Vera, Natural Colour.
| Device ID | K040503 |
| 510k Number | K040503 |
| Device Name: | ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR |
| Classification | Surgeon's Gloves |
| Applicant | WRP ASIA PACIFIC SDN. BHD. LOT1,JALAN3,KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI Sepang,selangor Darul Ehsan, MY 43900 |
| Contact | Terence Lim |
| Correspondent | Terence Lim WRP ASIA PACIFIC SDN. BHD. LOT1,JALAN3,KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI Sepang,selangor Darul Ehsan, 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 | 2004-02-27 |
| Decision Date | 2004-03-16 |
| Summary: | summary |