The following data is part of a premarket notification filed by Clean Medical Manfacturing Co;ltd with the FDA for Same/various Distributors/we May Private Label.
| Device ID | K112743 |
| 510k Number | K112743 |
| Device Name: | SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL |
| Classification | Vinyl Patient Examination Glove |
| Applicant | CLEAN MEDICAL MANFACTURING CO;LTD 18633 E. GALE AVE.#105 City Of Industry, CA 91748 |
| Contact | Aaron Richard |
| Correspondent | Aaron Richard CLEAN MEDICAL MANFACTURING CO;LTD 18633 E. GALE AVE.#105 City Of Industry, CA 91748 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-21 |
| Decision Date | 2011-12-16 |
| Summary: | summary |