The following data is part of a premarket notification filed by Dong Tai City Huayi Gloves Co.,ltd. with the FDA for Powder Free Blue Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs.
| Device ID | K211727 |
| 510k Number | K211727 |
| Device Name: | Powder Free Blue Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Dong Tai City Huayi Gloves Co.,Ltd. No.36 Nanzhuang Road, Dongtai High-tech Industrial Development Zone Dongtai, CN 224249 |
| Contact | Wang Huamei |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 East Lujiazui East 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 | 2021-06-04 |
| Decision Date | 2021-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973082130658 | K211727 | 000 |
| 06973082130672 | K211727 | 000 |
| 06973082130689 | K211727 | 000 |
| 06973082130696 | K211727 | 000 |
| 06973082130702 | K211727 | 000 |
| 06973082130719 | K211727 | 000 |
| 06973082130603 | K211727 | 000 |
| 06973082130610 | K211727 | 000 |
| 06973082130627 | K211727 | 000 |
| 06973082130634 | K211727 | 000 |
| 06973082130641 | K211727 | 000 |
| 06973082130665 | K211727 | 000 |