The following data is part of a premarket notification filed by Cabin Plastic Co., Ltd. with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K130751 |
| 510k Number | K130751 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | CABIN PLASTIC CO., LTD. RM 1606 BLDG. 1.JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD, HAIDIAN DISTRICT Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan CABIN PLASTIC CO., LTD. RM 1606 BLDG. 1.JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD, HAIDIAN DISTRICT 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 | 2013-03-19 |
| Decision Date | 2014-03-05 |
| Summary: | summary |