The following data is part of a premarket notification filed by Hebei Handform Plastic Products Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K082690 |
| 510k Number | K082690 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN, NO 209, BEI SI HUAN Zhong Road; Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN, NO 209, BEI SI HUAN Zhong Road; Beijing, CN 100083 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2009-02-09 |
| Summary: | summary |