The following data is part of a premarket notification filed by Beijing Reagent Latex Products Co., Ltd. with the FDA for Snow Lotus Powder-free Latex Surgeon's Gloves.
| Device ID | K012104 |
| 510k Number | K012104 |
| Device Name: | SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | BEIJING REAGENT LATEX PRODUCTS CO., LTD. NO. 30 SOUTH SANLITUN ROAD, DONGDAQIAO Chaowai, Beijing, P.r., CN 100020 |
| Contact | Wang Yannan |
| Correspondent | Wang Yannan BEIJING REAGENT LATEX PRODUCTS CO., LTD. NO. 30 SOUTH SANLITUN ROAD, DONGDAQIAO Chaowai, Beijing, P.r., CN 100020 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-05 |
| Decision Date | 2001-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16936610210229 | K012104 | 000 |
| 16936610210212 | K012104 | 000 |
| 16936610210205 | K012104 | 000 |
| 16936610210199 | K012104 | 000 |
| 16936610210182 | K012104 | 000 |
| 16936610210175 | K012104 | 000 |
| 16936610210168 | K012104 | 000 |
| 16936610210151 | K012104 | 000 |
| 06936610210147 | K012104 | 000 |