The following data is part of a premarket notification filed by Shandong Jianhong New Material Company with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K111752 |
| 510k Number | K111752 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANDONG JIANHONG NEW MATERIAL COMPANY ROOM 1606 BLDG, 1 JIAN XIANG YUAN NO.209 BEI SI Huan Zhong Rd, Beijing, CN 10083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan SHANDONG JIANHONG NEW MATERIAL COMPANY ROOM 1606 BLDG, 1 JIAN XIANG YUAN NO.209 BEI SI Huan Zhong Rd, Beijing, CN 10083 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-22 |
| Decision Date | 2011-07-27 |
| Summary: | summary |