The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Powder Free Green Latex Surgical Gloves, Sterile With Aloe Vera And Protein Content Labeling Claim (50 Microgram Less).
| Device ID | K022442 |
| 510k Number | K022442 |
| Device Name: | POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS) |
| 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 | Yue Wah Chow |
| Correspondent | Yue Wah Chow 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-25 |
| Decision Date | 2002-09-05 |
| Summary: | summary |