The following data is part of a premarket notification filed by Hebei Changsheng Plastic Products Co., Ltd. with the FDA for Powder Free Vinyl Patient Examination Gloves.
| Device ID | K113837 |
| 510k Number | K113837 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD. NO 99, HUANGJIN AVENUE, JULU COUNTY Xingtai, Hebei Province, CN 055250 |
| Contact | Richard Lu |
| Correspondent | Richard Lu HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD. NO 99, HUANGJIN AVENUE, JULU COUNTY Xingtai, Hebei Province, CN 055250 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-28 |
| Decision Date | 2012-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810073734999 | K113837 | 000 |
| 00810073734968 | K113837 | 000 |
| 00810073734937 | K113837 | 000 |
| 00810073734906 | K113837 | 000 |