The following data is part of a premarket notification filed by Taiwan An Lih Ent. Co. Ltd. with the FDA for Vinyl Examination Gloves.
| Device ID | K893338 |
| 510k Number | K893338 |
| Device Name: | VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TAIWAN AN LIH ENT. CO. LTD. NO. 12, SHUN TIEN RD, TA CHIA Chen Tai Chung Hsien, TW |
| Contact | Long Shi |
| Correspondent | Long Shi TAIWAN AN LIH ENT. CO. LTD. NO. 12, SHUN TIEN RD, TA CHIA Chen Tai Chung Hsien, TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-20 |
| Decision Date | 1989-09-15 |