The following data is part of a premarket notification filed by Shandong Feiyang Professional Gloves Company Limited with the FDA for Nitrile Examination Gloves, Powder Free, (white).
| Device ID | K152517 |
| 510k Number | K152517 |
| Device Name: | Nitrile Examination Gloves, Powder Free, (White) |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHANDONG FEIYANG PROFESSIONAL GLOVES COMPANY LIMITED 338 HUAQING DRIVE, QIXIN CHEMICAL INDUSTRY ZONE Qinzhou, CN 255400 |
| Contact | Ken Lu |
| Correspondent | Sophie Hao BASIC MEDICAL INDUSTRIES, INC. 12390 EAST END AVE Chino, CA 91710 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2016-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3408641XL1 | K152517 | 000 |
| B3408641L1 | K152517 | 000 |
| B3408641S1 | K152517 | 000 |
| B3408641M1 | K152517 | 000 |
| B340790373XL1 | K152517 | 000 |
| B340790370S1 | K152517 | 000 |
| B340790372L1 | K152517 | 000 |
| B340790371M1 | K152517 | 000 |
| B340790073M1 | K152517 | 000 |