The following data is part of a premarket notification filed by Lien Chang Rubber Industrial Co., Ltd. with the FDA for Latex Surgical Glove.
| Device ID | K881664 |
| 510k Number | K881664 |
| Device Name: | LATEX SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | LIEN CHANG RUBBER INDUSTRIAL CO., LTD. 16,LANE 472, SEC.4,CHANG SHUI HSING NUNG VILL. PEI TU HSIANG Chang Hua Hsien, Taiwan, TW |
| Contact | J. P Chen |
| Correspondent | J. P Chen LIEN CHANG RUBBER INDUSTRIAL CO., LTD. 16,LANE 472, SEC.4,CHANG SHUI HSING NUNG VILL. PEI TU HSIANG Chang Hua Hsien, Taiwan, TW |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-18 |
| Decision Date | 1989-01-06 |