The following data is part of a premarket notification filed by Hua Shu-yee Industrial Co., Ltd. with the FDA for Latex Examination Gloves.
| Device ID | K893352 |
| 510k Number | K893352 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | HUA SHU-YEE INDUSTRIAL CO., LTD. NO. 77-27 SHOW TSO ST. FU HSING HSIANG, CHANG HUA Hsien, Taiwan R.o.c., TW |
| Contact | Chun Tien |
| Correspondent | Chun Tien HUA SHU-YEE INDUSTRIAL CO., LTD. NO. 77-27 SHOW TSO ST. FU HSING HSIANG, CHANG HUA Hsien, Taiwan R.o.c., TW |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-21 |
| Decision Date | 1989-07-14 |