The following data is part of a premarket notification filed by Nantong Ruchang Latex Products Co., Ltd. with the FDA for Foxell, Mediguard, Plus Multiple Brand Names.
| Device ID | K964317 |
| 510k Number | K964317 |
| Device Name: | FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES |
| Classification | Latex Patient Examination Glove |
| Applicant | NANTONG RUCHANG LATEX PRODUCTS CO., LTD. 1314 HUNTER ST. Baltimore, MD 21202 |
| Contact | James F Logan |
| Correspondent | James F Logan NANTONG RUCHANG LATEX PRODUCTS CO., LTD. 1314 HUNTER ST. Baltimore, MD 21202 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-29 |
| Decision Date | 1997-01-24 |