The following data is part of a premarket notification filed by Cranberry (m) Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Gloves.
| Device ID | K983334 |
| 510k Number | K983334 |
| Device Name: | NITRILE POWDER FREE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | CRANBERRY (M) SDN. BHD. LOT 85, JALAN PORTLAND, TASEK INDUSTRIAL ESTATE Ipoh Perak, MY 31400 |
| Contact | Chong Yoon Tat |
| Correspondent | Chong Yoon Tat CRANBERRY (M) SDN. BHD. LOT 85, JALAN PORTLAND, TASEK INDUSTRIAL ESTATE Ipoh Perak, MY 31400 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-23 |
| Decision Date | 1999-02-19 |