The following data is part of a premarket notification filed by Anhui Anyu Latex Products Co., Ltd with the FDA for Annuy Latex Patient Examination Glove (powdered And Powder-free); Annuy Nitrile Patient Examination Glove (powdered And Powder-free).
| Device ID | K150612 |
| 510k Number | K150612 |
| Device Name: | Annuy Latex Patient Examination Glove (powdered And Powder-free); Annuy Nitrile Patient Examination Glove (powdered And Powder-free) |
| Classification | Latex Patient Examination Glove |
| 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 YUESHA BUILDING, NO.128 SONGLE RD., SONGJIANG AREA Shanghai, CN 201600 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06928965100068 | K150612 | 000 |
| 26928965100055 | K150612 | 000 |
| 26928965100048 | K150612 | 000 |
| 26928965100031 | K150612 | 000 |
| 26928965100024 | K150612 | 000 |
| 26928965100017 | K150612 | 000 |