The following data is part of a premarket notification filed by Dan Dong Linsen Plastic Industrial Co., Ltd. with the FDA for Pvc Examination Gloves.
| Device ID | K894752 |
| 510k Number | K894752 |
| Device Name: | PVC EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | DAN DONG LINSEN PLASTIC INDUSTRIAL CO., LTD. NO. 24 HEJING STREET, YUANBAO DISTRICT, DANDONG CITY Liaoning Province, China, CN |
| Contact | Lin Li |
| Correspondent | Lin Li DAN DONG LINSEN PLASTIC INDUSTRIAL CO., LTD. NO. 24 HEJING STREET, YUANBAO DISTRICT, DANDONG CITY Liaoning Province, China, CN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-26 |
| Decision Date | 1990-01-11 |