The following data is part of a premarket notification filed by Lee Ah Sheng Ent. Co., Ltd. with the FDA for Latex Examination Gloves.
| Device ID | K893295 |
| 510k Number | K893295 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | LEE AH SHENG ENT. CO., LTD. NO. 98-1, SHOW-TSUO ST., SHOW- TSUO VILLAGE, FU-HSING HSIANG Chang-hwa Hsien, Taiwan, TW |
| Contact | Leo Yen |
| Correspondent | Leo Yen LEE AH SHENG ENT. CO., LTD. NO. 98-1, SHOW-TSUO ST., SHOW- TSUO VILLAGE, FU-HSING HSIANG Chang-hwa Hsien, Taiwan, TW |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-18 |
| Decision Date | 1989-07-24 |