The following data is part of a premarket notification filed by Lien Chang Rubber Industrial Co., Ltd. with the FDA for Non-sterile Patient Examination Gloves.
| Device ID | K891938 |
| 510k Number | K891938 |
| Device Name: | NON-STERILE PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | LIEN CHANG RUBBER INDUSTRIAL CO., LTD. 16, LANE 472, SEC 4, CHANG SHUI RD. HSING NUNG VILLAGE Pai Tu Hsiang, Chang Hua, TW |
| Contact | J. P Chen |
| Correspondent | J. P Chen LIEN CHANG RUBBER INDUSTRIAL CO., LTD. 16, LANE 472, SEC 4, CHANG SHUI RD. HSING NUNG VILLAGE Pai Tu Hsiang, Chang Hua, TW |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-28 |
| Decision Date | 1989-05-08 |