The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Powdered Latex Surgiacal Gloves, Steerile With Expiration Date Labeling Claim.
| Device ID | K021159 |
| 510k Number | K021159 |
| Device Name: | POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM |
| 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 | K. K Leong |
| Correspondent | K. K Leong 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-11 |
| Decision Date | 2002-07-03 |
| Summary: | summary |