The following data is part of a premarket notification filed by Hebei Hongtai Plastic Products Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K102819 |
| 510k Number | K102819 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. ROOM 3-402, NO 71 MAJIAPU YANGQIAO, FENGTAI DIST Beijing, CN 100068 |
| Contact | Richard Lu |
| Correspondent | Richard Lu HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. ROOM 3-402, NO 71 MAJIAPU YANGQIAO, FENGTAI DIST Beijing, CN 100068 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-28 |
| Decision Date | 2010-12-23 |
| Summary: | summary |