The following data is part of a premarket notification filed by Shanghai Pm Plastics Ent. Co., Ltd. with the FDA for Disposable Pvc Synthetic Exam Gloves, Powder Free.
| Device ID | K001432 |
| 510k Number | K001432 |
| Device Name: | DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI PM PLASTICS ENT. CO., LTD. NO. 258, YUSHU RD. CHANGQIAO Township, Shohjiang County, Sh, CN |
| Contact | Chang T Sun |
| Correspondent | Chang T Sun SHANGHAI PM PLASTICS ENT. CO., LTD. NO. 258, YUSHU RD. CHANGQIAO Township, Shohjiang County, Sh, CN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-08 |
| Decision Date | 2000-07-05 |