The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-sterile.
| Device ID | K132484 |
| 510k Number | K132484 |
| Device Name: | DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900 |
| Contact | Kirk Penner |
| Correspondent | Kirk Penner WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-08 |
| Decision Date | 2013-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30851253007992 | K132484 | 000 |
| 30851253007985 | K132484 | 000 |
| 30851253007978 | K132484 | 000 |
| 30851253007961 | K132484 | 000 |