The following data is part of a premarket notification filed by Zibo Huiying Medical Products, Co. Ltd. with the FDA for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue.
| Device ID | K153028 |
| 510k Number | K153028 |
| Device Name: | Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO HUIYING MEDICAL PRODUCTS, CO. LTD. NO. 3 DA WU ROAD Linzi, CN 255400 |
| Contact | Fufang Wang |
| Correspondent | Sophie Hao BASIC MEDICAL INDUSTRIES, INC. 12390 East End Ave Chino, CA 91710 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-16 |
| Decision Date | 2016-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00097604794541 | K153028 | 000 |
| B845VGPF10143 | K153028 | 000 |
| B845BMPF30033 | K153028 | 000 |
| B845BMPF30023 | K153028 | 000 |
| B845BMPF30013 | K153028 | 000 |
| B845BMPF30003 | K153028 | 000 |
| 00840369300096 | K153028 | 000 |
| 00840369300065 | K153028 | 000 |
| 00840369300034 | K153028 | 000 |
| B845VGPF10153 | K153028 | 000 |
| B845VGPF10163 | K153028 | 000 |
| B845VGPF10173 | K153028 | 000 |
| 00097604794534 | K153028 | 000 |
| 00097604794527 | K153028 | 000 |
| 00097604794510 | K153028 | 000 |
| 20847212007908 | K153028 | 000 |
| B845BMPF20173 | K153028 | 000 |
| B845BMPF20163 | K153028 | 000 |
| B845BMPF20153 | K153028 | 000 |
| B845BMPF20143 | K153028 | 000 |
| 00840369300003 | K153028 | 000 |