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.
| Device ID | K101358 |
| 510k Number | K101358 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. ROOM 1606 BLDG 1 JIANXIANG YUAN NO 209 BEI SI HAUN ZHO 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 HAUN ZHO 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 | 2010-05-14 |
| Decision Date | 2010-08-24 |
| Summary: | summary |