The following data is part of a premarket notification filed by Profit Point Manufacturing Sdn Bhd with the FDA for Elegant Blue, White, Pink Powder Free, Nitrile Examination Gloves.
| Device ID | K101760 |
| 510k Number | K101760 |
| Device Name: | ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | PROFIT POINT MANUFACTURING SDN BHD JALAN MERSING KAWASAN PERIDUSTRIA Kluang, Johor, MY 86000 |
| Contact | Robert Hill |
| Correspondent | Robert Hill PROFIT POINT MANUFACTURING SDN BHD JALAN MERSING KAWASAN PERIDUSTRIA Kluang, Johor, MY 86000 |
| Product Code | LZA |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-23 |
| Decision Date | 2010-10-06 |