The following data is part of a premarket notification filed by Hongze Plastic Technology Co., Ltd with the FDA for Powder Free Vinyl Patient Examination Gloves (yellow, White,blue, Pink).
| Device ID | K101135 |
| 510k Number | K101135 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HONGZE PLASTIC TECHNOLOGY CO., LTD 1930 BREA CANYON RD Diamond Bar, CA 91765 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu HONGZE PLASTIC TECHNOLOGY CO., LTD 1930 BREA CANYON RD Diamond Bar, CA 91765 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-22 |
| Decision Date | 2010-07-01 |
| Summary: | summary |