The following data is part of a premarket notification filed by Profit Point Manufacturing Sdn Bhd with the FDA for Elegant Nitrile Powder Free Examination Glove Blue Violet.
| Device ID | K120110 |
| 510k Number | K120110 |
| Device Name: | ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET |
| Classification | Polymer Patient Examination Glove |
| Applicant | PROFIT POINT MANUFACTURING SDN BHD LOT PTD 27735 (PLO 9) 26624 (PLO 18) Kluang, MY 86000 |
| Contact | Robert Hill |
| Correspondent | Robert Hill PROFIT POINT MANUFACTURING SDN BHD LOT PTD 27735 (PLO 9) 26624 (PLO 18) Kluang, MY 86000 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-13 |
| Decision Date | 2012-10-04 |