The following data is part of a premarket notification filed by Guang Dong Kingfa Sci. & Tech.co., Ltd. with the FDA for Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs.
| Device ID | K213040 |
| 510k Number | K213040 |
| Device Name: | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Guang Dong Kingfa Sci. & Tech.Co., Ltd. No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, CN 511545 |
| Contact | Xiaoge Yu |
| Correspondent | Xiaoge Yu Guang Dong Kingfa Sci. & Tech.Co., Ltd. No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, CN 511545 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | OPJ |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-22 |
| Decision Date | 2022-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26975390736755 | K213040 | 000 |
| 00810160180043 | K213040 | 000 |
| 00810160180067 | K213040 | 000 |
| 00810160180074 | K213040 | 000 |
| 00810160180166 | K213040 | 000 |
| 00810160180173 | K213040 | 000 |
| 00810160180180 | K213040 | 000 |
| 00810160180197 | K213040 | 000 |
| 26975390734973 | K213040 | 000 |
| 26975390735017 | K213040 | 000 |
| 26975390736724 | K213040 | 000 |
| 26975390736731 | K213040 | 000 |
| 26975390736748 | K213040 | 000 |
| 00810160180050 | K213040 | 000 |