The following data is part of a premarket notification filed by Sun Flower Gloves Co., Ltd. with the FDA for Patient Examination Glove, Vinyl.
| Device ID | K891067 |
| 510k Number | K891067 |
| Device Name: | PATIENT EXAMINATION GLOVE, VINYL |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SUN FLOWER GLOVES CO., LTD. 187, CHIEN-EYH RD. SHAN-HUA, 74103 Tainan Hsien, Taiwan, TW |
| Contact | W. J Hu |
| Correspondent | W. J Hu SUN FLOWER GLOVES CO., LTD. 187, CHIEN-EYH RD. SHAN-HUA, 74103 Tainan Hsien, Taiwan, TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-01 |
| Decision Date | 1989-03-23 |