The following data is part of a premarket notification filed by Hebei Shenzichen Plastic & Rubber Products Co., Lt with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K100963 |
| 510k Number | K100963 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT 209 BEI SI HUAN ZHONG RD HAI D RM 1606 BLDG 1 JIAN XIANG YUAN Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT 209 BEI SI HUAN ZHONG RD HAI D RM 1606 BLDG 1 JIAN XIANG YUAN 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 | 2010-04-07 |
| Decision Date | 2010-08-06 |
| Summary: | summary |