The following data is part of a premarket notification filed by Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. with the FDA for Disposable Nitrile Powder-free Examination Gloves.
| Device ID | K213176 |
| 510k Number | K213176 |
| Device Name: | Disposable Nitrile Powder-Free Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. Guzhen Economic Development Zone Bengbu, CN 233799 |
| Contact | Kitty Xu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room608,No. 738,Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-28 |
| Decision Date | 2021-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975101540035 | K213176 | 000 |
| 06975101540028 | K213176 | 000 |
| 06975101540011 | K213176 | 000 |
| 06975101540004 | K213176 | 000 |