The following data is part of a premarket notification filed by Sun Flower Gloves Co., Ltd. with the FDA for Vinyl Examination Gloves Powder Free.
| Device ID | K974777 |
| 510k Number | K974777 |
| Device Name: | VINYL EXAMINATION GLOVES POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SUN FLOWER GLOVES CO., LTD. 3423 INVESTMENT BLVD. SUITE 12 Hayward, CA 94545 |
| Contact | David Hu |
| Correspondent | David Hu SUN FLOWER GLOVES CO., LTD. 3423 INVESTMENT BLVD. SUITE 12 Hayward, CA 94545 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-01-30 |