The following data is part of a premarket notification filed by Sheen More Ent. Co., Ltd. with the FDA for Disposable Powder Free Nitrile Exam Glove, Green Color.
| Device ID | K001637 |
| 510k Number | K001637 |
| Device Name: | DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHEEN MORE ENT. CO., LTD. NO.16, TOU KUNG SIX RD. TOU-LIU EXPANDED INDUST. PARK Tou-liu, Yun-lin, TW |
| Contact | Ken Huang |
| Correspondent | Ken Huang SHEEN MORE ENT. CO., LTD. NO.16, TOU KUNG SIX RD. TOU-LIU EXPANDED INDUST. PARK Tou-liu, Yun-lin, TW |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-30 |
| Decision Date | 2000-06-23 |