The following data is part of a premarket notification filed by Ever Growth (vietnam) Co., Ltd with the FDA for Disposable Powder Free Vinyl Exam Glove, Clear/yellow.
| Device ID | K172357 |
| 510k Number | K172357 |
| Device Name: | Disposable Powder Free Vinyl Exam Glove, Clear/Yellow |
| Classification | Vinyl Patient Examination Glove |
| Applicant | EVER GROWTH (VIETNAM) CO., LTD Long Khanh Industrial Zone, Binh Loc Ward Long Khanh Township, VN 810000 |
| Contact | Che-min Lee |
| Correspondent | Elizabeth Deng PM Gloves Inc. 7668 Belpine Place Rancho Cucamonga, CA 91730 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-03 |
| Decision Date | 2017-12-29 |