The following data is part of a premarket notification filed by Hong Huang Tang Industrial Co., Ltd. with the FDA for Disposable Powder Free Vinyl Synthetic Examination Gloves.
| Device ID | K974334 |
| 510k Number | K974334 |
| Device Name: | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HONG HUANG TANG INDUSTRIAL CO., LTD. NO. 1-1, NAN FUNG ROAD, FUNG LI LI, YUAN LI CHEN Miao Li Hsien, TW |
| Contact | Huan Chung-li |
| Correspondent | Huan Chung-li HONG HUANG TANG INDUSTRIAL CO., LTD. NO. 1-1, NAN FUNG ROAD, FUNG LI LI, YUAN LI CHEN Miao Li Hsien, TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-18 |
| Decision Date | 1998-01-09 |