The following data is part of a premarket notification filed by Anhui Anyu Latex Products Co., Ltd with the FDA for Annuy Latex Surgeon's Gloves (powdered And Powder Free).
| Device ID | K150609 |
| 510k Number | K150609 |
| Device Name: | Annuy Latex Surgeon's Gloves (Powdered And Powder Free) |
| Classification | Surgeon's Gloves |
| Applicant | ANHUI ANYU LATEX PRODUCTS CO., LTD EAST QINJI ROAD & NORTH XINGHUA ROAD, Bengbu, CN 233010 |
| Contact | None Provided |
| Correspondent | Doris Dong SHANGHAI CV TECHNOLOGY CO., LTD ROOM 1706, NO. 128 SONGLE RD., SONGJIANG AREA Shanghai, CN 201600 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-10 |
| Decision Date | 2015-11-16 |
| Summary: | summary |